Medical Device made Easy Podcast: Recent Episodes
Monir El Azzouzi
Quality and regulatory compliance are fundamental to bringing safe and effective medical devices to market. As regulations continue to evolve and technologies become more complex, manufacturers must adopt a proactive approach to quality throughout the entire product lifecycle.
This podcast collection explores key topics shaping today's medical device industry, including the FDA's transition to the Quality Management System Regulation (QMSR), effective validation and supplier management strategies, and structured approaches to managing software defects in Software as a Medical Device (SaMD).
Together, these discussions highlight how strong quality systems extend beyond documentation. They emphasize the importance of risk-based thinking, supplier oversight, software quality, and continuous improvement to ensure compliance while protecting patients.
Whether you're working in Quality Assurance, Regulatory Affairs, Engineering, or Product Development, these conversations offer practical insights to help strengthen your Quality Management System and prepare for the evolving regulatory landscape.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
What would happen if your Risk Management File disappeared tomorrow?
Would your medical device suddenly become less safe?
For many organizations, the answer is probably no—because the file was created to document decisions after they were made, rather than guiding those decisions in the first place.
In this episode of the Medical Device Made Easy Podcast, we challenge the traditional view of risk management and explore why ISO 14971 should be treated as a continuous decision-making framework—not simply a regulatory requirement.
What You'll Learn
Is Your Risk Management File Driving Design?
Risk management should begin at the earliest stages of product development.
Instead of documenting completed work, it should actively influence design choices, identify hazards, evaluate risks, and verify that risk control measures are effective throughout development.
Common Signs Your Risk File Is Becoming Fiction
Many organizations unintentionally weaken their risk management process by:
Reusing generic hazard lists from previous projects
Completing risk documentation just before certification
Failing to connect hazards with design decisions
Treating the Risk Management File as a static document instead of a living process
Risk Management Is a Cross-Functional Responsibility
Effective risk management isn't owned solely by Quality or Regulatory Affairs.
Engineering, Clinical Affairs, Manufacturing, Service, Post-Market Surveillance, and Customer Support all generate valuable information that should continuously improve the organization's understanding of product risk.
Why Traceability Matters
Strong traceability allows organizations to answer critical questions:
Why was this hazard identified?
Which design decision addressed it?
How was the risk control verified?
Does new PMS or complaint data change our understanding of the risk?
Would we make the same decision today?
When these connections are visible, risk management becomes a practical engineering tool rather than a compliance exercise.
Keeping Your Risk Management File Alive
Certification is not the end of risk management.
Complaints, vigilance reports, supplier changes, software updates, PMCF findings, literature reviews, and post-market surveillance all provide new information that should feed back into your risk assessment.
Organizations that continuously update their Risk Management File are better equipped to identify emerging risks, improve product safety, and support long-term regulatory compliance.
Key Takeaway
A Risk Management File should never exist simply to satisfy auditors or Notified Bodies.
Its real purpose is to demonstrate how risk-based thinking influences every important design decision throughout the product lifecycle.
The strongest organizations don't maintain a perfect document.
They maintain a living risk management process—one that evolves as new knowledge is gained and continuously helps make medical devices safer for patients.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Many medical device startups assume they're audit ready because they have documented procedures, completed templates, and a Quality Management System in place.
However, successful audits require much more than organized documentation.
In this episode of the Medical Device Made Easy Podcast, we welcome Chiratana Pot from Enlil to discuss what true audit readiness looks like and why continuous compliance is far more effective than preparing only when an audit is scheduled.
What You'll Learn
What Is an Audit Really?
Many organizations view audits as exercises designed to uncover mistakes.
In reality, audits evaluate whether your Quality Management System is implemented effectively and consistently—not simply whether procedures exist.
Compliance vs. Audit Readiness
Being compliant and being audit ready are not always the same.
The discussion explores how companies can move beyond documentation and demonstrate that their processes are actively followed throughout the organization.
Common Startup Mistakes
Drawing from experience working with MedTech startups, Chiratana shares the most frequent challenges organizations encounter before their first audit, including assumptions that often lead to unexpected findings.
Why Traceability Matters
One of the central themes of the episode is traceability.
We examine how effective traceability connects requirements, risks, design decisions, verification activities, and documentation—making change management more efficient and strengthening overall compliance.
How Enlil Supports Connected Development
The conversation concludes with an overview of Enlil's approach to connected development, explaining why integrating quality into product development from the beginning helps organizations maintain continuous audit readiness rather than relying on last-minute preparation.
Key Takeaway
Audit readiness is not a checklist completed before an inspection.
It's the result of building a culture where quality, traceability, and compliance are embedded into everyday work.
For MedTech startups, developing this mindset early can simplify audits, improve product quality, and create a stronger foundation for long-term regulatory success.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Who is Chiratana (CP) Pot?
Chiratana (CP) Pot is Senior Director of Product at Enlil, a cloud-native, AI-driven development traceability platform built for medical device and life sciences organizations. Enlil connects quality, regulatory, R&D, manufacturing, and operations teams through a unified system of record, enabling traceability, auditability, and regulatory readiness across the product lifecycle. CP works with MedTech organizations to strengthen design controls and audit readiness. He is a frequent contributor on topics including design controls, lifecycle traceability, and regulatory readiness, helping organizations move beyond documentation compliance to evidence-based product development.
Link
Chiratana's linkedin: https://www.linkedin.com/in/chiratana-pot/
Website: https://enlil.com/
Enlil’s LinkedIn: https://www.linkedin.com/company/enlil-inc/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
For many medical device startups, obtaining FDA clearance seems like a clear, linear process.
Identify a predicate device.
Prepare your documentation.
Submit your application.
Wait for clearance.
In reality, the journey is rarely that simple.
In this episode of the Medical Device Made Easy Podcast, Joanna Nathan, CEO of Prana Surgical, shares her firsthand experience navigating the FDA clearance process and discusses the challenges that many startups only discover after they begin.
Topics Covered
The Reality Behind FDA Clearance
When do founders realize the process is more complex than expected?
What would they do differently if they could start again?
Predicate Devices and Substantial Equivalence
Choosing the right predicate device is one of the most important strategic decisions in a 510(k) submission.
We discuss:
Predicate device selection
Intended use considerations
Technological characteristics
Common misconceptions about substantial equivalence
Building a Product with the FDA in Mind
The conversation explores how early regulatory decisions influence:
Product development
Testing strategy
Documentation
Risk management
Manufacturing planning
Working with the FDA
How valuable are Pre-Submission (Q-Sub) meetings?
What questions should manufacturers ask?
What mistakes should they avoid before engaging with the FDA?
Lessons Every Startup Should Know
Joanna shares practical advice on:
Unexpected FDA questions
Common causes of delays
Software validation
Biocompatibility
Usability studies
Documentation preparation
The biggest misconceptions surrounding FDA clearance
Key Takeaway
FDA clearance is much more than completing regulatory paperwork.
Successful companies integrate regulatory thinking into product development from the very beginning.
Making the right strategic decisions early can save significant time, reduce costs, and improve the likelihood of a successful FDA submission.
Whether you're launching your first medical device or preparing your next regulatory submission, this episode provides practical insights to help you navigate the FDA clearance journey with greater confidence.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Joanna’s LinkedIn: https://www.linkedin.com/in/joannacnathan
Prana System: https://www.pranasurgical.com/prana-system
Prana Surgical’s LinkedIn: https://www.linkedin.com/company/pranasurgical
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
For many medical device companies, a successful audit is seen as the ultimate proof that their Quality Management System is performing well.
Few or no findings.
Positive feedback from auditors.
Management celebrates.
But does passing an audit really mean your QMS is healthy?
In this episode of the Medical Device Made Easy Podcast, we explore why the answer is often no.
Audits Are Samples—Not Complete Evaluations
Whether it's an ISO 13485 audit, a Notified Body assessment, an FDA inspection, or an internal audit, auditors can only review a small sample of your quality system.
They cannot examine every complaint, every supplier, every design decision, or every production batch.
A successful audit demonstrates compliance with the sampled evidence—but it does not guarantee that every aspect of the system is functioning effectively.
The "Audit Mode" Problem
Many organizations unintentionally enter "Audit Mode" before inspections.
Training records are updated.
CAPAs are closed.
Procedures are revised.
Management reviews suddenly take place.
While preparation is important, organizations should ask themselves:
Are we improving our QMS—or simply preparing for an audit?
Culture Matters More Than Findings
Some of the most significant quality risks rarely appear during an audit.
Examples include:
Employees afraid to report mistakes
Poor communication between departments
Weak supplier relationships
Design decisions that are never challenged
Informal workarounds that bypass documented procedures
These issues can remain invisible during a short audit while gradually increasing organizational risk.
Measuring the Real Health of Your QMS
Instead of focusing only on audit findings, management should monitor indicators such as:
Complaint investigation timelines
CAPA closure performance
Supplier management effectiveness
Risk management updates
Cross-functional communication
Near-miss reporting
Continuous improvement initiatives
These metrics often provide a far more accurate picture of QMS maturity than the number of audit findings alone.
Final Thought
Passing an audit is an important achievement and deserves recognition.
However, organizations should never confuse regulatory compliance with operational excellence.
A healthy Quality Management System is not built to impress auditors.
It is built to consistently deliver safe, effective, and compliant medical devices while continuously improving every day—even when no auditor is watching.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Sponsor
Medboard: https://www.medboard.com/
Europe
Well-Established Technologies - Publication of the Delegated act: https://ec.europa.eu/newsroom/sante/newsletter-archives/77013
2 Delegated acts:
Class III and implantables: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451
Class Iib implantables: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359
In line with the Administrative Simplification Agenda
COMBINE Phase 2 - Increase of Scope : https://ec.europa.eu/newsroom/sante/newsletter-archives/76937
Incease of Scope:
Eligibility for multinational investigational medicinal product (IMP) clinical trials combined with:
Performance studies of IVDs or companion diagnostics requiring authorisation
Clinical investigations of medical devices requiring authorisation
Combined studies with Advanced Therapy Medicinal Products (ATMPs) possible
Options for single or separate sponsors
Procedure for substantial modifications in combined studies authorised in the pilot to be launched later in phase 2
Exploration of single protocols and joint documents
Austria: FSC deficiencies - Most issues identified: https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale/common-deficiencies
SSCP, Upload you should! - MDCG 2026-4 released: https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg_2026-4_en.pdf
Start Date October 2026, Due date February 2027
Harmonized Standard update - A full list was disclosed: https://eur-lex.europa.eu/eli/dec_impl/2026/1231/oj
MDCG 2021-5 Rev 1 EU REP Symbol -Should you continue to use EC REP? https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdf
During the transition time, within a staggered approach for the implementation, it is acceptable to use one or both symbols ‘EC REP’ and ‘EU REP’ on different levels of packaging, as well
Team-NB- Micro Small Entreprise - Discount imposed https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-Micro-Small-Entreprise-Initiatives-V1-20260616.pdf
UK
Update of UK Borderline Guide - Remove of antimicrobial substances as Medical Devices: https://www.gov.uk/government/publications/borderlines-with-medical-devices
The line: 'Alcohol-only pre-injection swabs and wipes are considered to be medical devices as are those containing anti-microbial substances such as chlorhexidine, cetrimide or iodine.'
has been changed to this:
Alcohol-only pre-injection swabs and wipes are considered to be medical devices.
Switzerland
Swissdamed: Registration
New option: M2M and Master UDI-DI: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/neu-online-editor-m2m-produktregistierung-master-udi.html
Swissdamed UDI User guide: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_841e_hb_swissdamed_user_guide_udi_devices_module.pdf.download.pdf/BW630_40_841e_HB_swissdamed_User_Guide_UDI_Devices_Module.pdf
Medtech Conf: Medtechconf.com
Podcast
Episode 393 - Best of „AI CE marking“: https://podcast.easymedicaldevice.com/393-2/
Episode 394 - NC vs CAPA: Are You Opening the Wrong Records?: https://podcast.easymedicaldevice.com/394-2/
Episode 395 - “We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices: https://podcast.easymedicaldevice.com/395-2/
Easy Medical Device
Consulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/
BOSS Program: Back Office Services
eQMS: https://easymedicaldevice.com/smarteye-eqms/
EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/
Authorized Representative in EU, UK and Switzerland
Market access all over the world: https://easymedicaldevice.com/services/market-access/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
At first glance, hearing "We've never had a complaint" sounds like excellent news.
No customer dissatisfaction.
No product issues.
No safety concerns.
But for Quality and Regulatory professionals, this statement should trigger an entirely different question:
How do you know?
What Is a Complaint?
Many organizations believe a complaint only exists when a customer submits an official complaint form or explicitly uses the word "complaint."
Regulators take a much broader view.
A complaint may include:
Unexpected device performance
Product malfunctions
Customer dissatisfaction
Usability issues
Distributor observations
Technical support interactions
Returned products
Any information suggesting the device may not meet requirements
Complaints Are Often Hidden
Potential complaint signals can be found in:
Customer emails
Distributor communications
Service reports
Sales team discussions
Training sessions
Social media comments
Technical support tickets
If these sources are ignored, valuable post-market information is lost.
Why Zero Complaints Can Be a Red Flag
Imagine a company with:
5,000 devices on the market
Products sold in 20 countries
Daily clinical use
And yet...
No complaints
No usability observations
No customer questions
No returned devices
Experienced auditors may not celebrate.
Instead, they may question whether the complaint handling process is effective enough to capture real-world information.
Complaint Handling Impacts the Entire Quality System
Weak complaint collection doesn't only affect one procedure.
It directly influences:
Clinical Evaluation Reports (CER)
Post-Market Surveillance (PMS)
PMCF activities
PSUR preparation
Benefit-Risk assessments
State-of-the-art reviews
If complaint data is incomplete, clinical evidence may also be incomplete.
Five Practical Recommendations
Define complaints broadly.
Review every customer-facing information source.
Create a structured complaint screening process.
Trend data regularly to identify recurring issues.
Periodically challenge your system by asking:
"Would an auditor agree that we've identified every potential complaint?"
Final Thought
The next time someone proudly says,
"We've never had a complaint,"
don't celebrate immediately.
Ask instead,
"How do we know?"
Because in medical devices, the absence of complaints is not always evidence that everything is working perfectly.
Sometimes, it's evidence that nobody is looking.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
One of the most common sources of confusion in medical device Quality Management Systems is knowing when to open a Nonconformity (NC) and when to initiate a Corrective and Preventive Action (CAPA).
Some organizations turn every issue into a CAPA, while others rarely open one at all. Both extremes can create challenges during audits and may indicate an immature quality system.
In this episode of the Medical Device Made Easy Podcast, we explain the fundamental differences between NCs and CAPAs and explore real-life situations to help quality professionals make better decisions.
A Nonconformity simply indicates that a requirement has not been met. A CAPA, however, is a structured process designed to investigate and eliminate the root cause of significant, recurring, or systemic issues.
Through multiple scenarios, we discuss:
When an isolated event should remain a simple NC.
How trends and recurring problems justify CAPAs.
Why a single event can trigger a CAPA when patient safety is involved.
Whether a CAPA always requires a Nonconformity first.
Alternative sources of CAPAs, including complaints, audits, PMS activities, PSUR reviews, PMCF activities, and management reviews.
How auditors evaluate the maturity of a CAPA system.
The three questions every quality professional should ask before deciding between an NC and a CAPA.
The objective is not to open more CAPAs, nor to avoid them. The objective is to open the right CAPAs, based on risk, recurrence, and impact.
Understanding this distinction is essential for building a robust and effective quality management system that supports compliance, patient safety, and continuous improvement.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate certification requirements and maintain safety and performance throughout the entire product lifecycle.
In two podcast episodes featuring Sandy Wright and Osman El-Koubani, we explore the journey from certifying LLM-driven medical devices to managing them after CE marking.
Certifying LLM-Driven Medical Devices
Large Language Models such as ChatGPT, Gemini, and Claude introduce new regulatory challenges. Unlike traditional software, these systems raise questions around predictability, validation, traceability, supplier management, and model updates.
Topics discussed include:
What defines an LLM-driven medical device
Clinical evaluation strategies
Demonstrating clinical benefit
Using commercial AI models
Supplier controls and external dependencies
Significant changes and model updates
Life After CE Marking
Obtaining CE certification is not the end of the journey.
AI medical devices require continuous monitoring once they reach the market.
Manufacturers must address:
Performance drift in real-world settings
Collection and analysis of real-world data
AI retraining and change management
Predetermined Change Control Plans (PCCPs)
Post-Market Surveillance (PMS)
Continuous safety and performance evaluation
AI Devices Require a Lifecycle Approach
AI systems are dynamic technologies. Success depends not only on achieving certification, but also on maintaining control over performance, updates, and clinical safety throughout the product lifecycle.
As regulations continue to evolve, manufacturers must combine robust development practices with proactive post-market monitoring to ensure long-term compliance and patient safety.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Sandy LinkedIn: https://www.linkedin.com/in/wrightsandy/
Osman Linkedin: https://www.linkedin.com/in/osman-kan/
Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Sponsor Medboard
Medboard: https://www.medboard.com/
EUROPE
Europe Starts Regulating the Regulators - Implementing Regulation (EU) 2026/977: https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
EUDAMED is mandatory - Panic is raising: https://health.ec.europa.eu/medical-devices-eudamed/overview_en
Germany: https://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte/DMIDS-anleitung-anzeigepflichtige-mp-ivd.pdf?__blob=publicationFile
Belgium: https://www.famhp.be/en/news/eudamed_clarifications_regarding_obligations_from_28_may_2026
Portugal: https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/13092901
AI Medical Devices - Timeline changed for AI ACT: https://www.consilium.europa.eu/en/press/press-releases/2026/05/07/artificial-intelligence-council-and-parliament-agree-to-simplify-and-streamline-rules/
Germany guidance: https://www.bundesnetzagentur.de/DE/Fachthemen/Digitales/KI/5_Innovationen/_DL/Roadmap_Pilot.pdf?__blob=publicationFile&v=5
Spain new HTA - Royal Decree 415/2026: https://www.boe.es/boe/dias/2026/05/29/pdfs/BOE-A-2026-11587.pdf
Denmark on languages - Reminder that there are requirements to follow: https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/
UK
MHRA regulatory advice meetings - Pay and ask what you want: https://www.gov.uk/guidance/medical-devices-ask-for-a-regulatory-advice-meeting-from-the-mhra
Easy Medical Device solutions
EasyIFU - electronic Instruction for Use: https://easyifu.com
Smarteye - electronic Quality Management System: https://eqms-smarteye.com/
Rest of the World
FDA reinforce Human Factors expectations - This is not nice to have: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions
Saudi Arabia bundling criteria - More products in a single application: https://www.sfda.gov.sa/sites/default/files/2026-05/MDS-G28.pdf
Podcast
Podcast Nostalgia - Re-listen latest podcast episodes:
Episode 390 - How can a proper intended use save your device with Kanrandeep Badwal: https://podcast.easymedicaldevice.com/390-2/
Episode 391 - Feedback after 3 months of the new FDA QMSR is in place with Mathangi Srinivasan: https://podcast.easymedicaldevice.com/391-2/
Easy Medical Device
Consulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/
BOSS Program: Back Office Services
eQMS: https://easymedicaldevice.com/smarteye-eqms/
EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/
Authorized Representative in EU, UK and Switzerland
Market access all over the world: https://easymedicaldevice.com/services/market-access/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
The FDA’s new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality System Regulation (QSR) framework that had been in place for nearly 30 years.
Three months later, the reality is becoming clear for many manufacturers:
QMSR is far more than a simple regulatory update.
It represents a complete transformation in how the FDA expects companies to manage quality, risk, design controls, manufacturing, supplier oversight, and post-market surveillance.
From Siloed Quality to Lifecycle Thinking
Under the old QSR framework, companies often treated quality activities separately:
Design controls
CAPA
Manufacturing
Supplier management
Post-market surveillance
QMSR changes this mindset entirely.
FDA now expects manufacturers to demonstrate integrated, risk-based quality management across the entire product lifecycle.
This means:
Design changes must connect to manufacturing validation
Supplier issues must feed into risk management
Post-market surveillance must proactively identify trends
Management reviews must show real decision-making
Why Many Companies Were Not Ready
A major misconception across the industry was believing that ISO 13485 certification automatically meant QMSR readiness.
But manufacturers are now discovering major gaps:
Incomplete Design History Files (DHF)
Weak risk integration
Poor documentation traceability
Reactive PMS systems
Limited management review evidence
FDA inspections are already reflecting these expectations.
Inspectors are requesting:
Internal audit reports
Supplier audit documentation
Management review records
Risk-based decision evidence
This level of transparency is new for many organizations.
Real-World Challenges Manufacturers Are Facing
One of the biggest pain points is DHF restructuring.
Companies with years of design changes are now being forced to reconstruct the logic behind historical decisions and organize fragmented information into a coherent, risk-based structure.
Another major shift is Post-Market Surveillance.
QMSR pushes manufacturers from reactive complaint handling toward proactive monitoring of known high-risk failure modes using trend analysis, registries, and real-world data.
Management review processes are also under greater scrutiny.
FDA now expects leadership teams to demonstrate how quality data drives actual strategic decisions.
Best Practices for QMSR Transition
Manufacturers preparing for QMSR should focus on:
- Cross-functional collaboration
Break down silos between QA, RA, Manufacturing, Design, and Supply Chain.
- Documentation mapping
Identify where critical design logic and risk decisions currently exist.
- Continuous risk management
Implement ongoing cross-functional risk review meetings.
- Stronger internal audits
Move beyond checklist auditing toward analytical risk-focused auditing.
- Meaningful management reviews
Use management review meetings to demonstrate active leadership involvement in quality decisions.
Final Thoughts
QMSR is fundamentally changing the FDA’s expectations.
Companies that adapt early will build stronger systems, improve product quality, and reduce regulatory risk.
Companies that delay may face:
FDA 483 observations
Warning Letters
Product launch delays
Increased remediation costs
The transition to QMSR is not simply a compliance project.
It is a complete redesign of how medical device companies manage quality.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Mathangi Srinivasan linkedin: https://www.linkedin.com/in/mathangiks/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
A medical device’s intended use is not just a regulatory formality — it is the foundation of the entire product strategy.
In this podcast episode, Monir El Azzouzi speaks with Karandeep Badwal about how intended use influences classification, clinical evaluation, risk management, labeling, and ultimately market access.
The discussion explores why many companies underestimate the importance of intended use and how poorly written statements can create major downstream regulatory problems. From Software as a Medical Device (SaMD) to AI-driven products, the episode highlights real-world examples where unclear intended use created challenges during certification and compliance activities.
The episode also provides practical guidance for manufacturers on:
Defining a robust intended use statement
Aligning intended use with clinical evidence and risk management
Avoiding “labeling tricks” that may trigger regulatory scrutiny
Building internal collaboration between regulatory, clinical, and product teams
This is an essential discussion for MedTech startups, QA/RA professionals, and manufacturers navigating MDR, IVDR, FDA, or global regulatory pathways.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
karandeepbadwal linkedin: https://www.linkedin.com/in/karandeepbadwal/
qra-medical linkedin: https://www.linkedin.com/company/qra-medical/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Sponsor: Medboard
https://www.medboard.com/
Europe
EUDAMED: It's Go Time -May 28th 2026 for New Products:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1860&qid=1720686388639
https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf
Brand new Notified Body Rules -Implementation regulation 2026/977
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
https://www.medtecheurope.org/resource-library/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/
EU MDR IVDR Simplification Proposal - 2 tracks
https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2025/1023/COM_COM(2025)1023_EN.pdf
EMA Breakthrough Medical Devices Pilot - Just launched
https://www.ema.europa.eu/en/news/new-pilot-support-development-breakthrough-medical-devices
https://www.ema.europa.eu/en/documents/presentation/presentation-breakthrough-medical-devices-pilot-information-sessio_en.pdf
MIR form update - Update your files or links:
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en
Switzerland
Swissdamed device Registration - July 1st is coming
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/produktregistrierung.html
Swissmedic's 2026 PMS Focus Campaign - Class Iia, Iib and III
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/info-ueberpruefung-dokumentation-zur-ueberwachung-nach-inverkehrbringen.html
UK
MHRA proposes indefinite CE Mark Recognition - Poll is closed
https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices
New UK Clinical Trials Framework -Live Since April 28th
https://www.gov.uk/government/news/launch-of-clinical-trial-reforms
New MHRA fees + Faster Incident Reporting - Reminder to budget and update procedures.
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees
https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/vigilance-reporting-requirements
MHRA Medical Devices (Amendment) Regulations 2026 - Brand New, Your Input Needed
https://www.gov.uk/government/news/mhra-invites-views-on-proposed-changes-to-medical-device-regulation
Events
Medtech Summit - June 15-16, 2026 in Berlin, Germany
https://informaconnect.com/medtech-summit
European Medical Device Supplier Excellence Conference - June 9-11th, 2026 - Brussels, Belgium
https://medicaldevicesupplierexcellence.com/
International
USA — FDA Launches - AI Platform HALO and Upgrades Elsa to 4.0
https://www.fda.gov/news-events/press-announcements/fda-expands-ai-capabilities-and-completes-data-platform-consolidation
Canada: Two changes happening — Mandatory Digital Submissions + New AI/ML Device Guidance
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/mandatory-use-regulatory-enrolment-process-notice-to-industry.html
https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices/pre-market-guidance-machine-learning-enabled-medical-devices.pdf
Podcast
Podcast Nostalgia
Episode 384: AI Medical Devices: What Notified Bodies Really Look for (Camille Petri): https://podcast.easymedicaldevice.com/384-2/
Episode 385: The Fake QMS Problem: Why your ISO 13485 System will fail and Audit: https://podcast.easymedicaldevice.com/385-2/
Episode 386: Life after CE Marking: Why AI Medical Devices Need Continuous Monitoring (Osman El-Kouban): https://podcast.easymedicaldevice.com/386-2/
Episode 387: Master UDI-DI: The New Layer many Medtech Companies don't Understand (Hussam Mostafa): https://podcast.easymedicaldevice.com/387-2/
Episode 388: Certifying LLM-Driven medical devices (Sandy Wright): https://podcast.easymedicaldevice.com/388-2/
Easy Medical Device
Consulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/
BOSS Program: Back Office Services
eQMS: https://easymedicaldevice.com/smarteye-eqms/
EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/
Authorized Representative in EU, UK and Switzerland
Market access all over the world: https://easymedicaldevice.com/services/market-access/
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Unique Device Identification (UDI) has become a central element of medical device compliance worldwide.
From EUDAMED in Europe to FDA databases in the United States, regulators increasingly rely on accurate UDI data to improve traceability and patient safety.
But many manufacturers underestimate one important reality:
👉 A small UDI mistake can become extremely expensive.
Why UDI Accuracy Matters
UDI is not simply a number placed on a label.
It is a structured identification system connected to:
• Device traceability
• Regulatory databases
• Market surveillance
• Recalls
• Post-market monitoring
When UDI data is incorrect or incomplete, the impact can quickly spread across the entire quality and regulatory system.
The Real Risks of Incorrect UDI Data
An incorrectly calculated or poorly structured UDI can lead to:
Product Recalls
If products cannot be correctly identified, companies may need to perform recalls or field actions.
Database Errors
Incorrect submissions to EUDAMED or FDA databases may prevent customers and authorities from accessing accurate device information.
Traceability Gaps
Without proper identification, tracking affected products becomes difficult during complaints or vigilance activities.
Financial Costs
Fixing UDI errors after commercialization often requires:
• Relabeling
• Database corrections
• Regulatory updates
• Internal investigations
All of these consume significant time and resources.
Why Many Companies Struggle
UDI implementation often requires coordination between:
• Regulatory Affairs
• Quality
• Supply Chain
• IT
• Manufacturing
Many organizations discover inconsistencies in:
• Device families
• Packaging hierarchies
• Certificates
• Product configurations
Without strong governance, errors become inevitable.
Best Practices to Avoid UDI Problems
Manufacturers should:
✔ Validate UDI structures early
✔ Review regulatory guidance carefully
✔ Audit device data regularly
✔ Test database submissions before launch
✔ Ensure cross-functional ownership of UDI data
Final Thought
UDI mistakes are rarely “small” problems.
In MedTech, inaccurate identification can affect compliance, operational efficiency, and ultimately patient safety.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Sandy LinkedIn: https://www.linkedin.com/in/wrightsandy/
Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.
Now, Europe is introducing an additional layer: Master UDI-DI — adding both structure and complexity to the system.
Understanding the UDI Structure
To fully understand Master UDI-DI, it’s important to distinguish between the different levels:
• UDI-DI → Identifies a specific device
• Basic UDI-DI → Groups devices with the same intended purpose and characteristics
• Master UDI-DI → Applies to highly individualized devices with specific design parameters
This new layer aims to better manage products with high variability.
Why Master UDI-DI Was Introduced
For certain devices — such as spectacle frames, lenses, and other customizable products — the number of variations can become overwhelming.
Master UDI-DI helps:
• Reduce the number of identifiers required
• Improve traceability
• Simplify product grouping
• Enhance recall efficiency
Key Benefits
Despite its complexity, Master UDI-DI brings several advantages:
✔ Better organization of device data
✔ Improved market surveillance
✔ Faster identification during recalls
✔ Stronger protection against counterfeit products
Challenges for Manufacturers
However, the implementation is not without challenges:
• Increased data requirements
• Risk of incorrect UDI assignment
• Need for cross-functional coordination
• Integration with EUDAMED
As highlighted in the discussion, errors in UDI can be costly — including recalls and data inconsistencies.
Timeline and Urgency
While the labeling deadline is set for November 2028, manufacturers should not wait.
EUDAMED requirements are already active, and preparation takes time.
👉 Early implementation reduces risk, cost, and operational pressure.
Best Practices
To ensure compliance, manufacturers should:
• Study MDCG guidance documents
• Validate data before submission
• Use tools for UDI calculation
• Involve project managers and cross-functional teams
• Seek expert support when needed
Who is Al Hajj Sam Mostafa?
Al Hajj Sam Mostafa is founder and CEO of UDI Experts. He has nearly 10 years of UDI experience, in which he leads and provides his premiere UDI solutions to MedTech organizations. One of his prestige clients is of the Magnificent Seven (Big Tech) companies. UDI Experts continuously strives to offer their clients the best UDI services for the best prices. Their global services include medical device data collection, data registration, UDI label creation and UDI label support, UDI printing IQ/OQ/PQ, and much more.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Website: www.udiexperts.com
Business LinkedIn: www.linkedin.com/in/udi-experts-600138189
Personal LinkedIn: www.linkedin.com/in/al-hajj-sam-m-03b69612
YouTube UDI Video for Dawa Medical (below)
Import IQ: Episode 5 Understanding the UDI with Hussam Mustafa
UDI Experts YouTube Channel: www.youtube.com/@UDIExperts-o3z
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it is only the beginning.
In this episode, Osman El-Koubani shares insights into the post-market realities of AI as a Medical Device (SaMD) and what manufacturers must do to remain compliant over time.
CE Certification Is Not the Finish Line
Many companies assume that once their device is certified, the main regulatory burden is over.
In reality, Post-Market Surveillance (PMS) becomes critical — especially for AI systems that can evolve or degrade in real-world conditions.
Relaxing after certification can lead to:
• Loss of control over performance
• Undetected risks
• Regulatory non-compliance
AI in the Real World: Performance Drift
AI models often behave differently once exposed to real-world data. This phenomenon, known as performance drift, can reduce accuracy and reliability over time.
Manufacturers must implement continuous monitoring strategies, including:
• Real-world data (RWD) collection
• Performance tracking
• Feedback loops for improvement
Updating AI Devices: What Is Allowed?
Updating AI systems introduces regulatory complexity.
Key questions include:
• What qualifies as a significant change?
• Does retraining require re-certification?
• How should updates be documented and justified?
Manufacturers often struggle with these decisions, leading to compliance risks.
PCCP: Enabling Controlled Evolution
The concept of a Predetermined Change Control Plan (PCCP) allows manufacturers to define in advance how an AI system can evolve.
While this concept is gaining traction globally, its implementation in Europe is still evolving and requires careful regulatory consideration.
Building a Mature AI PMS System
A robust post-market system for AI devices should include:
• Continuous performance monitoring
• Risk management integration
• Clear documentation of updates
• Strong governance of data and models
Who is Osman El-Koubani
Dr Osman El-Koubani is a doctor and clinical researcher. With nearly a decade of experience at the intersection of healthcare, digital innovation, and AI, he has developed and implemented NHS digital solutions and advised multiple software and AI medical device startups. At Scarlet, Osman works as a Clinical Engineer and AI/ML expert, leading clinical evaluation, risk management, and usability for AI-driven medical devices, while also helping SaMD and AIaMD manufacturers navigate certification and maintain compliance through transparent, practical, and safety-focused regulatory processes.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Many medical device companies believe they have a compliant Quality Management System (QMS).
On paper, everything looks perfect:
• Procedures are written
• Forms are available
• Risk management is documented
• CAPA systems are defined
But during an audit, everything falls apart.
What Is a “Fake QMS”?
A fake QMS is not necessarily incorrect — it is simply not implemented in reality.
Employees may not understand it.
Processes may not be followed.
Evidence may not exist.
In short:
👉 The system exists… but it is not alive.
Why This Happens
There are three common causes:
- Copy-Paste Systems
Companies reuse QMS from other organizations without adapting them to their own operations.
- Template-Based QMS
Generic ISO 13485 packages provide documentation — but no real implementation.
- Consultant-Driven Systems
Consultants build the QMS, but knowledge is never transferred internally.
When they leave, the system collapses.
What Happens During an Audit
Auditors don’t just review documents — they test your system.
Examples include:
• CAPA: Can you explain root cause analysis?
• Risk Management: Do you link PMS data to risk updates?
• Training: Do employees understand their responsibilities?
If the answer is no, nonconformities follow.
The Core Problem
A QMS is not documentation.
👉 It is a living system based on real processes and evidence.
How to Build a Real QMS
To avoid this trap, companies should:
• Build processes based on real operations
• Keep procedures simple and usable
• Define clear responsibilities
• Train employees effectively
• Create traceable evidence
• Use an eQMS for control and integration
• Test the system internally before audits
Final Takeaway
A fake QMS is not just a compliance issue — it is a business risk.
It can lead to:
• Audit failures
• Delays in certification
• Loss of credibility
ISO 13485 is not about having documents.
👉 It’s about proving that your system works.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and personalized healthcare solutions. However, with this innovation comes increased regulatory complexity.
In this episode, Camille Petri shares insights into how Notified Bodies assess AI-based medical devices and what manufacturers need to prepare for successful certification.
Are AI Devices More Difficult to Certify?
Compared to traditional software, AI-based medical devices introduce additional layers of complexity. These include data dependency, algorithm behavior, and potential variability in performance.
Notified Bodies are therefore placing greater emphasis on transparency, traceability, and robustness.
Data: The Foundation of AI Certification
One of the most critical elements in AI certification is the quality of data.
Manufacturers must clearly document:
• Training datasets
• Validation datasets
• Test datasets
Common deficiencies include poor dataset representativeness, lack of traceability, and insufficient justification of data selection.
Clinical Evaluation for AI
Clinical evaluation for AI devices differs from traditional approaches.
Regulators may accept retrospective data in some cases, but increasingly expect strong clinical evidence demonstrating real-world performance.
The challenge lies in proving that the AI system performs consistently across different populations and use cases.
Risk Management in AI
AI introduces new types of risks, including:
• Algorithm bias
• Performance drift over time
• Lack of explainability
Manufacturers must integrate these risks into their risk management process, in line with ISO 14971.
Performance, Validation & Continuous Learning
A key question for regulators is how to manage AI systems that evolve over time.
Notified Bodies often differentiate between:
• Locked algorithms (fixed behavior)
• Continuous learning systems (adaptive models)
Each approach has different regulatory implications, particularly regarding validation and post-market monitoring.
Key Takeaway
AI in MedTech offers tremendous opportunities, but certification requires a strong foundation in data, clinical evidence, and risk management.
Understanding what Notified Bodies expect early in development can significantly improve your chances of a successful submission.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Camille Petri Linkedin: https://www.linkedin.com/in/camillepetri/
Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Medboard
Sponsor: Medboard: https://www.medboard.com/
EU
Extension of WET Class Iib - A new list with new products mentioned: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2026)1809
Update your MIR form - Version 7.3.1: https://health.ec.europa.eu/document/download/e8ce9f53-82cb-44c8-a06e-91ad71c16b01_en?filename=md_new-reg_mir-form-v7.3.1_en.pdf
UK
Future Regulation -Implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
Consultation on indefinite recognition of CE marked medical devices and current transitional arrangements
Pre-market Statutory Instrument (SI)
Future Enhancemens: Exceptional Use Authorization and Health Institution exemption
Post-market Surveillance Requirements
Update to guidances
Learn Clinical Investigation in the UK - Lot of questions answered:
Clinical investigations for electrically powered devices : https://www.gov.uk/government/publications/clinical-investigations-for-electrically-powered-devices/clinical-investigations-for-electrically-powered-devices
Clinical investigations: investigators' responsibilities : https://www.gov.uk/government/publications/clinical-investigations-investigators-responsibilities/guidance-for-clincal-investigators
Clinical investigations: statistical considerations : https://www.gov.uk/government/publications/clinical-investigations-statistical-considerations/statistical-considerations
Medical devices that need a clinical investigation: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation
Determining if Clinical Investigation is required: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation/determining-if-a-clinical-investigations-is-required
Clinical Investigation Flow chart: https://assets.publishing.service.gov.uk/media/696f850b5b6060ca6736a0ae/flow_chart_for_clinical_investigations_v3.png
Events
Team NB: Training IVDR -July 2nd 2026: https://www.team-nb.org/wp-content/uploads/2026/03/Leaflet-IVD-TD-Manufacturers-Training-20260702.pdf
Egypt: Vigilance reporting Training - April 7 to 9, 2026: https://tinyurl.com/emdpodcast
MedtechConf.com - Check the MAPEU
Swiss Medtech Day 2026 - June 10, 2026: https://medtechconf.com/event/why-swiss-medtech-day-matters-what-you-should-know/
Medtech Forum - May 11, 2026: https://medtechconf.com/event/the-medtech-forum-2026-shaping-the-future-of-medical-technology-in-europe/
US
Veeva Medtech US Summit- May 11. 2026: https://medtechconf.com/event/veeva-medtech-us-summit-2026-innovation-data-modernization-in-medical-devices/
Brazil
Hospitalar - May 19,2026: https://medtechconf.com/event/hospitalar-the-reference-event-for-healthcare-innovation-and-solutions-in-latin-america/
RoW
Australia: Software Advertisment -What to say: https://www.tga.gov.au/resources/guidance/advertising-software-based-medical-devices-australia
Your advertisement must contain:
an accurate description of the device
the trade name of the device
the intended purpose(s) of the device
any mandatory statements and, where relevant, health warnings.
For example, you must not:
claim your product is “TGA approved”
make unsubstantiated claims about the product’s performance
include endorsements or testimonials from health professionals or medical researchers.
Malaysia: Guidance Creation/Update - Medical Device Act 2012
Guidance on Definition of Medical Devices: https://portal.mda.gov.my/index.php/announcement/1777-publication-of-second-edition-of-guidance-document-on-definition-of-medical-devices
Guidance on confirmation of obsolete and discontinued medical device: https://portal.mda.gov.my/index.php/announcement/1778-publication-of-first-edition-of-guidance-document-on-application-for-confirmation-status-of-obsolete-and-discontinued-medical-devices
Guidance on import and/or supply of unregistered medical devices under special access exemption application: https://portal.mda.gov.my/index.php/announcement/1779-publication-of-third-edition-of-guidance-document-on-import-and-or-supply-of-unregistered-medical-devices-under-special-access-exemption-application
India: FAQ on IVD products - 24 questions with answers: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-Doc-No-CDSCOIVDFAQ-042022dated-13032026.pdf
Egypt: What you need to register - List of documents: https://tinyurl.com/EmdEgyptRegistration
Podcast
Podcast Nostalgia -Let's remember: https://podcast.easymedicaldevice.com/
Episode 381: EUDAMED deadline 2026: https://podcast.easymedicaldevice.com/381-2/
Episode 382: Best-of of 3 podcasts: https://podcast.easymedicaldevice.com/382-2/
Service
New Website: https://easymedicaldevice.com
Authorized Representative
Consulting
Training
EasyIFU: https://easyifu.com
Smarteye: https://eqms-smarteye.com/
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges.
To help you stay ahead, we’ve gathered the most valuable insights from three MedTech podcasts into one concise summary.
In this article/video, we explore:
Key regulatory challenges related to FDA and MDR
Common mistakes that delay device approval
Strategic advice from industry experts
These insights highlight one essential truth: success in MedTech is not only about innovation, but also about understanding regulatory pathways and execution.
Whether you are a startup founder, regulatory professional, or industry enthusiast, these lessons will help
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
The upcoming EUDAMED deadline on May 28, 2026, marks a major shift in how regulatory data is managed under the EU MDR and IVDR.
While many companies believe this transition is simply about uploading documents into a European database, the reality is far more complex.
EUDAMED is not just a database — it is becoming the central regulatory infrastructure of the European medical device ecosystem, connecting manufacturers, notified bodies, regulators, and economic operators.
Why EUDAMED Matters
EUDAMED aims to increase:
• Transparency
• Traceability
• Post-market surveillance
• Regulatory oversight
To achieve this, companies must ensure that their internal data is structured, accurate, and aligned with regulatory expectations.
The Biggest Mistake
The most common misconception is treating EUDAMED as an IT project.
In reality, it is a data governance challenge.
Before uploading any device, companies must clearly define:
• Device families
• Basic UDI-DI and UDI-DI
• Certificate linkage
• Legal manufacturer responsibilities
Many organizations struggle with these fundamentals.
The 7-Step Readiness Checklist
To prepare effectively, QA/RA teams should focus on:
Actor registration (SRN)
Cleaning the device portfolio
Validating the UDI structure
Checking certificate data
Defining legacy device strategy
Assigning data ownership
Performing a dry run
Risks of Delayed Preparation
Companies that delay preparation may face:
• Incomplete or inconsistent data
• Registration delays
• Regulatory bottlenecks
• Internal confusion
EUDAMED could quickly become a regulatory traffic jam for unprepared organizations.
A Practical Timeline
To avoid these risks:
• Immediately: Audit all regulatory data
• Next 1–2 months: Validate UDI structure and device hierarchy
• Before the deadline: Perform a full readiness simulation
Final Takeaway
EUDAMED is not just a compliance requirement — it is a transformation of how regulatory information is managed in Europe.
Companies that prepare early will transition smoothly.
Those that wait may face significant delays and operational challenges.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Medboard
Sponsor: Medboard: https://www.medboard.com/
Europe
Pharmacist are distributors - French guide issued to educate them: https://medboard-public-assets.s3.amazonaws.com/Regulatory/9b892d08-611c-4326-a40e-750e0364df27.pdf
Team NB
Team NB position Paper - Reduced Scrutiny, Cost saving: https://www.team-nb.org/wp-content/uploads/2026/03/Team-NB-PositionPaper-MDR-IVDR-revision-impact-on-the-sector-20260302.pdf
Team-NB Demonstrate Safety and performance - For Combination of reagent and other equipment: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-PositionPaper-Demonstration-of-Safety-and-Performance-for-Combinatorial-Use-of-Devices-or-Equipment-V1-20260216.pdf
Team-NB- Letter on Cybersecurity - New Proposal again: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdf
Team-NB - MDR Clinical & Tech File Training - Check the dates: https://medboard-public-assets.s3.amazonaws.com/Regulatory/442102-Leaflet-MDR-Clinical-Manufacturers-Training-20260528.pdf and https://www.team-nb.org/wp-content/uploads/2026/02/Leaflet-MDR-TD-Manufacturers-Training-20260429.pdf
UK
Consultation on recognizing CE mark - Should it be indefinitely: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices
Consultation until: April 10, 2026
UK Reliance is ongoing - Draft proposal to recognize MDSAP and other: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices
Bookmark the MHRA contact page -Whispering If you want to Whistleblow, there is a contact Chuuut!!!: https://www.gov.uk/guidance/contact-mhra
Solutions
EasyIFU: For eifu and Label - Test it for Free: https://easyifu.com
Smarteye: for eQMS . Ask for a Demo: https://eqms-smarteye.com/
RoW
IMDRF
Reliance Playbook - With examples to apply: https://www.imdrf.org/sites/default/files/2026-02/IMDRF%20GRRP%20WG%20N89%20Reliance%20Playbook.pdf
USA
FDA Cybersecurity documentation - Final Guidance: https://www.fda.gov/media/119933/download
Malaysia
Launch of the Innovative Pathway - Accelerate the development of your device: https://portal.mda.gov.my/index.php/announcement/1771-implementation-of-the-innovative-medical-device-review-pathway-by-medical-device-authority-ministry-of-health-malaysia
Argentina
Self Declaration expended for Low-Risk devices - Themis platform to be used: https://www.argentina.gob.ar/noticias/entra-en-vigencia-el-nuevo-regimen-simplificado-para-la-habilitacion-de-establecimientos
Podcast
Episode 376 - Defect Management in SaMD with Anindya Mookerjea: https://podcast.easymedicaldevice.com/376-2/
Episode 377 - IEC 60601 4th edition with Leo Eisner: https://podcast.easymedicaldevice.com/377-2/
Episode 378 - IMDRF & Regulatory Reliance with Stephanie Grassmann: https://podcast.easymedicaldevice.com/378-2/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across multiple countries. This duplication slows innovation and delays patient access to life-saving technologies.
To address this challenge, international regulators are increasingly collaborating through the International Medical Device Regulators Forum (IMDRF).
In this podcast episode, Stephanie Grassmann (MedTechXperts) joins us to discuss how the concept of Regulatory Reliance is transforming global medical device approvals.
What is IMDRF?
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of regulatory authorities working together to harmonize medical device regulations and reduce duplication across global markets.
Members include major regulatory bodies such as:
• United States (FDA)
• European Union
• Australia (TGA)
• Brazil (ANVISA)
• Canada (Health Canada)
• China (NMPA)
Their mission is to promote efficient regulation while maintaining high standards of safety and performance.
Understanding Regulatory Reliance
Regulatory reliance allows one authority to give significant weight to the work already performed by another trusted regulator.
Instead of repeating full assessments, authorities can leverage existing evaluations, reducing regulatory burden while maintaining confidence in safety and effectiveness.
Real-World Success Stories
Several regulators are already demonstrating the benefits of reliance mechanisms.
Australia – TGA
A Class III Mitral Valve Clip reached market access in just 20 working days after the regulator accepted evidence generated overseas.
Argentina – ANMAT
Dental instruments known as endodontic barbed broaches were approved in 9 working days using reliance pathways.
Brazil – ANVISA
Companies holding MDSAP certification may skip immediate on-site audits, saving both time and money during market entry.
These examples show how regulatory cooperation can significantly accelerate approvals.
The Role of MDSAP
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single regulatory audit recognized by multiple countries.
This program plays a key role in enabling reliance between regulatory authorities and reducing redundant inspections.
The European Perspective
Europe has historically maintained a distinct regulatory framework under EU MDR and IVDR.
However, recent proposals—including references to Articles 108a and 108b—suggest increasing collaboration with international frameworks such as IMDRF and MDSAP.
While a single global approval system remains a long-term goal, reliance initiatives are already demonstrating that cooperation between regulators can improve efficiency without compromising safety.
Looking Ahead
For manufacturers and startups, embracing international regulatory frameworks early—such as MDSAP and IMDRF guidance—can significantly improve global market access strategies.
As regulatory collaboration grows, the future of medical device approvals may become faster, more harmonized, and more patient-centered.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Stephanie Grassmann Linkedin: https://www.linkedin.com/in/stephaniegrassmann-medtechxperts/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk-based philosophy introduced in the 3rd edition, the standard has continuously evolved to address technological and regulatory complexity.
Now, the upcoming 4th edition represents more than an amendment — it signals a structural transformation.
This article explores:
The Evolution of IEC 60601
• Key shifts from the 2nd to the 3rd edition
• Why risk management became central
• What lessons shaped today’s safety philosophy
What the 4th Edition Brings
• A major rewrite rather than incremental updates
• The introduction of “atomic requirements”
• Structural clarity for manufacturers, test labs, and regulators
• Emerging technical considerations (digitalization, AI, cybersecurity, home use)
Impact on Existing Devices
• Will re-testing be required?
• How to assess validity of existing test reports
• Transition strategies with notified bodies
Integration into Design & Documentation
• Embedding IEC 60601 into risk management from day one
• Required updates in risk files, EMC documentation, labeling, and usability engineering
• Practical advice for SMEs with limited resources
The Future of IEC 60601
• Greater harmonization with ISO 14971 and IEC 62304
• Alignment with digital and AI regulatory frameworks
• The long-term outlook for medical electrical safety
For manufacturers, the message is clear:
IEC 60601 is not just a testing standard — it is a design and risk management framework that must be integrated early and strategically.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Leo Linkedin: https://www.linkedin.com/in/leoeisnersafetyconsultants/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient safety, regulatory compliance, and product lifecycle control.
This article (and podcast episode) explores both foundational and advanced perspectives on defect management in regulated software environments.
We cover:
Understanding Defects in SaMD
• What defines a defect in a regulated context
• How defect management differs from non-medical software
• The relationship between defects, risk management, and ISO 14971
Building a Compliant Defect Management Process
• Essential documentation and tools
• Severity and priority categorization
• Handling defects discovered during validation or post-market
• Differentiating between defects, change requests, and requirement gaps
Advanced & Real-World Scenarios
• Managing safety-critical defects
• When CAPA or vigilance reporting is required
• Handling SOUP and third-party component issues
• Ensuring traceability across versions and product variants
• Agile defect management strategies
Audit Perspective & Common Pitfalls
• Frequent gaps identified by regulators and notified bodies
• How defect trend data supports CAPA and management review
• Practical advice for startups implementing lightweight but compliant systems
We also discuss how modern eQMS platforms (such as SmartEye) can help streamline documentation, automate traceability, and improve oversight without adding unnecessary bureaucracy.
Defect management in SaMD is not about documentation — it’s about maintaining control over risk and ensuring safe, effective software throughout its lifecycle.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Simon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
SPONSOR
Medboard: https://www.medboard.com/
EUROPE
New Harmonization Standards - Implementing Decision 2026/193:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193
Neurosurgical implants
EN ISO 14155:2020 on clinical investigations
EN ISO 18562 series on Biocompatibility for Breathing gas pathways
Germany: Transition from DMIDS to EUDAMED - March 19, 2026:
https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770EUDAMED mandatory by May 28th, 2026
High-Level Conference on Medical Devices - March 16th, 2026 - Brussels:
https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_en
The conference will feature three breakout sessions focusing on:
Enhanced predictability for conformity assessments: combining certainty with flexibility
Clinical evidence at EU level to support the regulatory framework: the key role of Expert Panels
Breakthrough technologies for better care: turning guidance into reality
Team-NB: Letter on Cybersecurity - MDR and IVDR proposal draft version:
https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdf
Switzerland
Swissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf
Swissdamed Webinar - May 28th, 2026:
https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.html
UK
UK to exempt Health Institution - Not a priority for now
https://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devices
Training
Team-NB: Training on MDR technical Documentation - For manufacturers on April 19th, 2026:
https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/
EasyIFU
Create eIFU and Labels easily - Compliance to EU MDR/IVDR:
Https://easyifu.com
RoW
North America
FDA: General Wellness devices - Guidance by the FDA:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices
FDA: Cybersecurity in Medical Devices - QMS and Pre-market submission:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket
APAC
Malaysia: Electronic Certificates issued by MDA - For FSC, Manufacturing Certificates and Export Certificates
https://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysia
India: Import of IVD - Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3D
Africa
Egypt: Database for Product Registration -Online Electronic Service:
https://eservicesdata.edaegypt.gov.eg/MedicalDevices
Middle East
Saudi Arabia: SFDA inspection of QMS requirements - Process that would be followed:
https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdf
Podcast
Episode 372 - How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/
Episode 373 - QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/
Episode 374 - Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/
Services
Consulting support: info@easymedicaldevice.com
Authorized Representative: EO@easymedicaldevice.com
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development.
Key topics discussed include:
Test Method Validation: definition, regulatory expectations, and when it is required
FDA warning letters and the risks of non-compliant validation approaches
Common pitfalls and best practices for Test Method Validation
Process Validation and Packaging Validation
The role of statistics in MedTech, including sample size justification
Risk management linked to validation activities
Supplier management, from sourcing components to audits and long-term supplier development
Simon also explains how SIFO MEDICAL supports medical device manufacturers through consulting and online training focused on:
Process validation and equipment qualification
Test Method Validation training
ISO 13485 and 21 CFR 820.30 compliance
Supply chain development, including injection molding and cleanroom manufacturing environments
This episode is essential for quality managers, regulatory professionals, validation engineers, and MedTech manufacturers looking to strengthen compliance, avoid warning letters, and build robust validation strategies.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Simon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.
But starting February 2nd, 2026, FDA will implement QMSR, changing not only the regulation structure but also the inspection philosophy.
QMSR does not eliminate Part 820. Instead, FDA is amending it to incorporate ISO 13485:2016 by reference, bringing the US closer to the global quality language used across Europe, Canada, Japan, and beyond.
Why FDA is doing this
FDA’s move is driven by three key goals:
Harmonization (reduce duplicated systems and audits)
Modern quality thinking (move from “procedures” to “system effectiveness and risk”)
Inspection efficiency (more end-to-end audits)
What inspections may look like under QMSR
Instead of jumping between SOPs, inspections may follow real flows like:
Complaint → Risk Management → CAPA → Design Change → Supplier Impact
The focus becomes traceability, consistency, and risk-based justification.
What companies should do now
To be QMSR-ready, companies should:
Build an ISO 13485-style process map
Make risk visible everywhere, not only in product development
Improve CAPA triage and effectiveness checks
Strengthen design controls (especially software development & V&V)
Train teams on the new “why/how” inspection style
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
📩 If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
🌍 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework changes.
In this podcast episode, we provide a structured and practical discussion on:
The definition and purpose of a DHF
Key differences between FDA QMSR and ISO 13485 requirements
How the DHF concept is addressed within ISO 13485
When DHF remediation becomes unavoidable
Typical causes of remediation, including accumulated DHF debt
How to remediate a DHF without creating new compliance risks
Common pitfalls and practices to avoid
How to define a realistic and defensible remediation strategy
Regulatory communication considerations with:
National Competent Authorities
Notified Bodies
This episode is based on an article developed by Wega Informatik AG and is intended to help MedTech professionals approach DHF remediation in a controlled, transparent, and compliant way.
If you are responsible for design controls, quality systems, or regulatory compliance, this episode will help you avoid costly mistakes and build confidence in your remediation approach.
Links
Richie Christian Linkedin: https://www.linkedin.com/in/christianrichie/
https://www.wega-it.com/remediation-of-medical-device-design-history-file/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Medboard: https://www.medboard.com/
Europe
EMD Mag Issue 3 - For QA RA people: https://easymedicaldevice.com/emd-mag/
EU to simplify MDR and IVDR - Proposal ongoing: https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf - https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_25_3078/QANDA_25_3078_EN.pdf - https://ec.europa.eu/commission/presscorner/api/files/attachment/882087/FACTSHEET%20medical%20devices%20final%20(1).pdf
Team NB Position Paper on Annex VII - Not agreeing all EU Proposal: https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216.pdf
MDCG 2025-9 Learn Breakthrough Devices BtX - Guidance for innovative products: https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
Infographic: https://www.linkedin.com/posts/melazzouzi_medtech-mdr-ivdr-activity-7414590943179202560-jbxH?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI
MDCG 2025-10 on PMS - Learn how to do it with this guidance: https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf
Notified Body Malta Conformity Assessment - 52nd Notified Body for MDR: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=SIMS_INPUT_282916&filter=notificationStatusId:1
Services
EasyIFU - Manage your eIFU and Labels: https://easyifu.com
Switzerland
Swissdamed registration deadline - July 1st 2026: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/frist-produktregistrierung-in-swissdamed.html - https://swissdamed-webinar.ch/#E402A0
UK
MHRA Price changing -: More cost for manufacturers: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees
RoW
FDA: How to use Real World Evidence - Guidance Document offered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices
Australia: Preparing for UDI and AusUDID - Checklist for preparation available: https://www.tga.gov.au/sites/default/files/2025-12/preparing-for-udi-in-australia-checklist_0.pdf
Podcast
Podcast Nostalgia - What was discussed lastly:
Episode 367 - From Engineer to Clinical Evaluation Expert - Florian Tolkmitt: https://podcast.easymedicaldevice.com/367-2/
Episode 368 - Simplifying EU MDR IVDR with Adam Isaacs Rae: https://podcast.easymedicaldevice.com/368-2/
Episode 369 - Last Podcast of the Year: https://podcast.easymedicaldevice.com/369-2/
Episode 370 - Verification & Validation with Aaron Joseph: https://podcast.easymedicaldevice.com/370-2/
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most challenging phases for many teams.
In this podcast episode, we sit down with Aaron Joseph, medical device development expert and author of the well-known article “Top 10 V&V Fails”, to explore why V&V so often becomes a source of stress — and how teams can do better.
Throughout the discussion, we cover:
A clear, simple explanation of Verification vs. Validation
Why V&V must span the entire development lifecycle
How poor requirements create downstream V&V failures
The risks of starting V&V planning too late
How to simplify test methods without losing rigor
Practical strategies for handling failed tests
How to think about traceability without fear
The future of V&V as software and AI become more prevalent
This episode is designed to educate, demystify, and inspire QA/RA professionals, engineers, and MedTech leaders looking to build stronger, more resilient development processes.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Aaron Joseph Linkedin: https://www.linkedin.com/in/ajosephprofile/
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026.
The episode reflects on a full year of continuous content creation, including:
Weekly podcast episodes covering global medical device regulations
Increased focus on artificial intelligence and its impact on QA/RA roles
Educational initiatives such as EMD Mag, designed to make complex regulatory topics more accessible
Development of digital tools like EasyIFU, labeling automation, and eQMS solutions
Expansion of consulting, back-office services, and international presence
The discussion also addresses upcoming challenges:
Increasing pressure on Notified Bodies
Risks for late MDR/IVDR transitions
The importance of anticipation and regulatory strategy for new and existing manufacturers
More than a recap, this episode is a strategic pause — an opportunity to reflect, learn, and prepare for the years ahead in a rapidly evolving medtech regulatory environment.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability.
In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety.
The discussion covers:
Key shortcomings of the current MDR/IVDR framework
The impact on innovation, availability of devices, and SMEs
The eight reform pillars, including proportionality, digitalisation, international cooperation, and improved coordination with EMA and Notified Bodies
How upcoming EU legislation (AI Act, Cybersecurity Act, Biotech Act) will interact with medical device regulations
This episode provides practical insights for manufacturers, regulatory professionals, and policymakers seeking to anticipate regulatory changes and adapt their strategies accordingly.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
Adam Linkedin: https://www.linkedin.com/in/adam-isaacs-rae/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter:
https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Clinical Evaluation has become one of the most critical — and challenging — domains under the EU MDR. But how does one build real expertise in this field?
In this episode of the Medical Device Made Easy podcast, Monir El Azzouzi interviews Florian Tolkmitt, Clinical Evaluation Expert at Pro-Liance, to explore his journey from engineering into clinical evaluation and regulatory science.
The discussion covers:
Florian’s education and early career path
How he specialized in Clinical Evaluation
Key lessons learned since the implementation of the EU MDR
What Notified Bodies really expect from clinical documentation
Frequent mistakes manufacturers make in clinical submissions
The evolving role of consultants in supporting compliance
How AI and digital tools may transform literature review and evidence generation
Advice for young professionals entering the MedTech field
This episode offers practical insights, career inspiration, and forward-looking perspectives for anyone working — or aspiring to work — in clinical evaluation and regulatory affairs.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
Linkedin florian: https://www.linkedin.com/in/florian-tolkmitt-clinical-evaluation/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Medboard
Europe
48% disruption in the EU - I hope you are all healthy: https://health.ec.europa.eu/document/download/13b2c812-b144-4489-af1f-e76af5bc97fd_en?filename=md_availability_study_presentation_2024.pdf
Consultation: SCHEER asks you - Are Brain Stimulators for non-medical purpose dangerous: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-scientific-opinion-health-hazards-and-risks-associated-use_en
Q&A Medicines used with Medical Devices - Revision 6 with new questions: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
EUDAMED is Mandatory - From 28 May 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502371 - https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
UK
Better Call MHRA - But we don't consult: https://www.gov.uk/guidance/medical-devices-get-regulatory-advice-from-the-mhra
Standard
ISO 10993-1 mutation - Nothing is automatic anymore: https://www.youtube.com/watch?v=AkSZVNSz5a0
ISO 18969 draft - Comments until 28-01-2026: https://www.youtube.com/watch?v=zCR9HlHJ5l0
EasyIFU
Create your Labels with EasyIFU - UDI included: https://easyifu.com
Rest of the World
Argentina
Argentina: Simplified application - Class I/A or Class II/B: https://www.argentina.gob.ar/noticias/anmat-establece-un-regimen-simplificado-para-la-habilitacion-de-establecimientos
Canada
Canada: Modernization of the MDEL - Some changes: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-modernizing-mdel-framework-phase-ii.html
Canada: Medical Device License Application - Guidance on how to do it: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses.html
Brazil
Brazil: Digitalisation of Certificates - You can request that online now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-lanca-nova-ferramenta-para-emitir-certificados-de-dispositivos-medicos
Podcast
Podcast Nostalgia - Let's review previous podcasts
Episode 363 - The journey of a CRO with Helene Quie: https://podcast.easymedicaldevice.com/363-2/
Episode 364 - What is changing with the new ISO 10993-1 with Marina Daineko: https://podcast.easymedicaldevice.com/364-2/
Episode 365 - How to become a Lead Auditor with Rob Packard: https://podcast.easymedicaldevice.com/365-2/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical role in evaluating QMS performance, improving compliance, and preparing organizations for ISO certification.
In this podcast episode, we explore:
🔹 What is a Lead Auditor?
The responsibilities, authority, and role differences between internal audits, supplier audits, and certification audits.
🔹 Who can become a Lead Auditor?
The competencies required, background expectations, and what makes a good auditor.
🔹 What you must learn to be effective:
ISO 19011 — the core auditing guideline
ISO 13485 — the medical device QMS standard
ISO 14971 — risk management for medical devices
Software lifecycle & technical documentation considerations
🔹 Do Lead Auditor certificates expire?
Clarifying the myth around renewal, competency maintenance, and the expectations of certification bodies.
🔹 Spotlight: Lead Auditor Training by Medical Device Academy
We review the upcoming training course, covering:
Curriculum and learning objectives
Exam format
Prerequisites
Pricing
Training dates
Certificate details
👉 Learn more or register here: https://medicaldeviceacademy.com/lead-auditor-training/
This episode is ideal for QA/RA specialists, QMS managers, consultants, and anyone aiming to take a leadership role in medical device auditing.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions.
Will we need to retest everything?
Is this a complete game-changer, or just an evolution?
How will Notified Bodies and the FDA react?
In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi hosts Marina Daineko, biocompatibility consultant at Intrinsic Medical Group, to unpack what’s really coming.
This episode covers:
The background and current status of the ISO 10993-1 revision
Why the new version is best seen as an evolution, not a revolution
How the standard pushes further into a risk-based, scientifically justified approach
The link with ISO 14971 and lifecycle thinking
Changes in contact categorization and cumulative exposure
The industry trend toward reducing animal testing through in vitro methods and data-driven justification
How to conduct a gap analysis once the new standard is published
Practical advice on how to prioritize updates without freezing projects or panicking
Real-world examples where process chemicals, not base materials, changed the risk picture
How Intrinsic Medical Group supports companies with biological evaluation, cleanliness, sterilization and reusable devices
👉 If you’re involved in RA/QA, R&D, toxicology, or clinical development, this conversation gives you a practical roadmap for navigating the transition to the new ISO 10993-1.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
Marina Daineko Linkedin: https://www.linkedin.com/in/marinadaineko/
Intrinsic Medical Group, LLC: https://www.linkedin.com/company/intrinsic-medical-group/posts/?feedView=all
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
In this long-form interview, Helene Quie, founder of Qmed Consulting, shares an inside look at nearly 20 years of experience in clinical and regulatory consulting for medical devices.
This article covers:
- Helene’s personal journey from employee to entrepreneur
- The early risks and decisions that shaped Qmed’s growth
- How the company’s services and markets evolved over time
- A deep dive into clinical evidence generation vs equivalence
- The seismic impact of EU MDR on clinical strategies
- PMCF pitfalls and real-life examples
- Working with Notified Bodies and new expectations under MDR
- Lessons from projects that didn’t go as planned
- The crucial alignment between clinical data and human factors
- Practical advice for startups on avoiding top regulatory mistakes
- Her vision of the future: RWE, adaptive study designs, digital health & greater regulatory convergence
Links:
Helene Quie: https://www.linkedin.com/in/helene-quie-863a323/
Qmed Consulting: https://qmed-consulting.com/
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
MedBoard
EU
Joint clinical assessment procedure - EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086
Team-NB position paper on Companion diagnostics - Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf
MDR and IVDR put at risk transplantation - Donor Screening and SoHo preparation: https://www.edqm.eu/documents/52006/162284/PA-PH-TO%20%2824%29%2018%20%E2%80%93%20Risks%20to%20safety%20and%20quality%20in%20donor%20screening%20and%20SoHO%20preparations%20due%20to%20poor%20implementation%20of%20the%20MDR%20and%20IVDR%20%E2%80%93%20CD-P-TO%20Position%20paper%20%E2%80%93%20October%202025.pdf/51d5efb2-4611-13ad-76a0-b5710b371248
Dedicated proportionate regulatory pathway for Niche fields
Article 5(5.g) requirements to the highest risk categories (Health institutions to create documentation for the products)
Update of MDCG guidance on In-house devices to better reflect the operational reality.
Off-label use and RUO are not falling on Article 5.5 so grey zone.
Team-NB proposal for MDR & IVDR - 5 topics on the agenda: https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/
Early dialogue: Use of this to talk to Notified Bodies
Article 61.10 & WET: Update for more clarity. Narrow the scope.
Digitalisation: Machine readable documents, AI to support simulations to reduce Animal testing.
Coding for MD and IVD
Designation and recertification: For Notified Bodies
Breakthrough: Coordinated pathway with challenge to generate Clinical Data.
Notified Bodies Count - S New comers for MDR and IVDR:
SGS Fimko oy (IVDR 19): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1016921
ICIM S.P.A. (MDR 51) : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43747&filter=notificationStatusId:1
Notice (MDR): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1020121
Standards
New Harmonized Standards - Clothing and sterilisers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502078
Biocompatibility
ISO TS 23485: https://www.linkedin.com/posts/melazzouzi_iso13485-iso-medicaldevice-activity-7393773266689228801-d7LM?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI
UK Reliance with US FDA - Harmonization is ongoing: https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai
Service
eIFU with free access -Test it and let us know : https://Easyifu.com
eQMS for a structured Quality Management System - Get your demo: https://eqms-smarteye.com/
Magazine
eMagazine . EMD Mag Free- Are Notified Bodies still the right model: https://easymedicaldevice.com/emd-mag/
ROW
US FDA: Pre-RFD -:Combination product: https://www.fda.gov/media/189466/download
US FDA: QMSR guidelines -: How to create a QMS: https://www.fda.gov/media/189345/download
PODCAST
Podcast review - What happened in October 2025
Episode 357 - Highlights from La Rentrée du DM 2025: https://podcast.easymedicaldevice.com/357-2/
Episode 358 - Clinical Evidence under EU MDR - Why so many dossier fail (And how to fix it): https://podcast.easymedicaldevice.com/358-2/
Episode 359 - Real World Evidence - How to use it right for FDA and EU: https://podcast.easymedicaldevice.com/359-2/
Episode 360: US Government Shutdown - What FDA can still be doing? Rob Packard: https://podcast.easymedicaldevice.com/360-2/
Episode 361 - Automatisation of your QA RA Job with AI - Hatem Rabeh: https://podcast.easymedicaldevice.com/361-2/
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs.
In this podcast episode, Hatem Rabeh joins to demystify how AI can be used — and where it must be handled carefully.
We discuss:
The reality behind “AI replacing QA/RA jobs”
Key tools: n8n, Make, Zapier, OpenAI, and OpenFDA
Building automation workflows for regulatory monitoring and documentation
Managing data privacy, confidentiality, and local vs cloud solutions
The cost, setup time, and risks of AI hallucination
How to use AI safely and ethically in regulated environments
👉 By the end, you’ll know how to build smart workflows that save time, ensure compliance, and keep human oversight where it matters most.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
US Government Shutdown – What the FDA Can Still Be Doing?
When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, the uncertainty can be alarming.
In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers.
You’ll learn:
Which FDA activities continue, and which are suspended
How submissions like 510(k), PMA, and De Novo are impacted
What happens to clinical trials, recalls, and ongoing investigations
Whether this situation has happened before and how long it could last
How companies can prepare and what contingency actions to take
💡 Rob also shares practical advice for manufacturers seeking FDA support during this period, as well as insights into how his team can assist in maintaining compliance and communication continuity.
If you’re part of the medical device ecosystem — this is essential reading.
Tags: FDA, Medical Devices, Regulatory Compliance, Quality Management, US Government Shutdown, Rob Packard, Clinical Trials
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly.
In this episode, we break down what RWE really means, how it differs between the FDA and the EU MDR, and how you can design a compliant, global strategy that turns data into regulatory strength.
You’ll learn:
What qualifies as Real-World Data (RWD) and Real-World Evidence (RWE)
How the FDA integrates RWE into premarket submissions (510(k), De Novo, PMA)
How EU MDR uses RWE through PMCF and PMS
The key differences in approach between the two regions
A practical 5-step roadmap to build a compliant RWE strategy
Common pitfalls (bias, poor traceability, privacy issues) — and how to avoid them
💡 Whether you’re in Regulatory Affairs, Clinical Affairs, or Quality Assurance, this episode gives you a clear framework to make Real-World Evidence a competitive advantage, not a compliance headache.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities.
This episode breaks down the root causes behind failed submissions and offers a practical framework to fix them:
Understanding the shift from MDD to MDR (Article 61 & Annex XIV)
Why weak Clinical Evaluation Plans (CEPs) lead to rejection
How to generate and analyze real, device-specific clinical data
Integrating Post-Market Clinical Follow-up (PMCF) into your PMS system
Maintaining a “living” Clinical Evaluation Report across the device lifecycle
👉 By following this checklist, you’ll not only pass your next review but also strengthen your evidence strategy for long-term compliance.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of European and global medical device regulation.
Main themes included:
Updates on EU MDR/IVDR and new regulatory initiatives in France
Structured dialogue with Notified Bodies and the harmonization of technical documentation
Post-market discontinuation and the importance of anticipation for patient safety
Eco-design and sustainability, bridging healthcare and environmental responsibility
Software and AI in clinical investigations, and the use of real-world data
Global market access – EU vs US pathways and MDSAP recognition
Technical deep dives into ISO 13485, biocompatibility, usability, and cybersecurity
The consensus was clear: regulatory pressure is increasing, but collaboration, innovation, and anticipation remain the keys to success.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
Site web larentreedudm: https://www.larentreedudm.com
Linkedin poste: https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381678647151112192-WQqX?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQhttps://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381670070097297408-80sP?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ
https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381641922739609600-HXhq?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ
https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381639827718447104-SQs-?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ
https://www.linkedin.com/posts/melazzouzi_medicaldevice-regulatoryaffairs-easymedicaldevice-activity-7381629520535060480-kJ0p?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ
https://www.linkedin.com/posts/melazzouzi_medicaldevices-regulatoryaffairs-easymedicaldevice-activity-7381602405030711296-aHcv?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Medboard
Europe
TToo much Incomplete Tech File - Let's explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf
2025/1920 on Master UDI-DI - Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920
Borderline manual Update - New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf
red blood cell additive solutions containing adenine
dual action cream with menthol and capsaicin
Lactose tablets for vaginal use
microabrasion dental stain removers
medical examination table covers
Mobile sterile air system
EU asks your feedback on EU MDR and IVDR - Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en
Switzerland
Swissdamed Technical Documentation - XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html
Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf
UK
UK PMS guidance for Report - Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system
PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report
Magazine
Issue 1: Sept/Oct 2025 - Next one will come November 2025: https://easymedicaldevice.com/emd-mag/
Events
Medtech Conf events - Be listed on the MAP: https://medtechconf.com/events-map-2/
EasyIFU
Free trial for eIFU with EASYIFU - Compliant EU 2025/1234: https://easyifu.com
ROW
US FDA Computer System Assurance - SOP offered on the show notes: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0
Malaysia affiliate member of MDSAP - What does it change?: https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member
Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist
Egypt guidance to import your devices - Medical Devices, Accessories, IVD:
All type of devices: https://edaegypt.gov.eg/media/lafopofx/1-regulatory-guideline-of-issuance-of-import-approvals-of-all-types-of-medical-devices_gd.pdf
Medical Equipment and Accessories: https://edaegypt.gov.eg/media/fltnd1qc/4-regulatory-guideline-of-issuing-import-approvals-for-medical-equipment-and-their-accessories_gd.pdf
IVD: https://edaegypt.gov.eg/media/e2rf4qg5/2-regulatory-guideline-of-the-procedures-and-rules-of-obtaining-import-approvals-for-iaboratory-and-diagnostic-equipment-gd.pdf
Podcast
Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/
Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/
Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/
Easy Medical Device Service
Support for Consulting (QA RA projects)
Support for Authorized Representative and Market Access
Integration to an eQMS
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Post-Market Surveillance for Software & AI Devices – A QA/RA Guide
Software evolves with updates. AI models may even change with real-world data. That makes Post-Market Surveillance (PMS) for digital medical devices very different from traditional hardware.
In this article, based on the podcast episode, we cover:
How PMS differs for software, cloud, and AI-based devices
Usage monitoring & anomaly detection through dashboards and KPIs
Revalidation of updates and retrained AI algorithms
Regulatory frameworks: EU MDR/IVDR, FDA’s PCCP, IMDRF guidelines
Supplier and infrastructure considerations
A step-by-step PMS workflow for QA/RA teams
Real-world case study on AI performance drift
👉 We conclude with a practical checklist to help QA/RA teams ensure compliance while keeping patients safe.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
From Surgeon to CEO: Prof. Marc Possover’s Inspiring Journey in Medical Innovation
The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this evolution felt like a natural extension of his life’s mission: to improve patient outcomes and expand access to advanced treatments in pelvic neurosurgery.
In this exclusive episode of the Medical Device Made Easy Podcast, host Monir El Azzouzi invites Prof. Possover to share his story—one that blends clinical excellence, entrepreneurial vision, and a deep commitment to education.
A Career Built on Medical Breakthroughs
Prof. Possover is internationally recognized as a pioneer in neuropelveology, a specialty dedicated to treating complex pelvic nerve disorders. Over the years, he has developed innovative procedures that offer hope to patients suffering from chronic pain and dysfunctions once considered untreatable. But his ambition has always reached beyond the operating room. By founding his own medical company, he sought to transform groundbreaking surgical techniques into accessible, reproducible therapies that benefit patients worldwide.
Why a Surgeon Became a CEO
Moving from the precision of surgery to the strategic demands of business might seem like a dramatic shift, but for Prof. Possover it was a continuation of his mission. Becoming a CEO meant taking responsibility not only for individual patients but for the future of the treatments themselves. Leadership allowed him to guide product development, secure resources, and create an ecosystem where new therapies could flourish well beyond his own practice.
As he explains in the podcast, “At some point I will retire—or die—but what will remain are the colleagues I trained.” His decision to lead a company ensures that his techniques will survive and continue to evolve, creating impact that outlasts any single career.
Patient Education as a Driving Force
Throughout the conversation, Prof. Possover emphasizes the vital role of patient education. When patients are aware of new treatment options, they actively seek qualified specialists, creating a natural demand for innovation. This patient-driven movement pressures the medical community to adopt cutting-edge solutions and ensures that life-changing therapies reach those who need them most.
By offering information sessions and open discussions, he empowers patients to become advocates for their own health—transforming the doctor–patient relationship into a true partnership.
Building a Global Legacy Through Training
Prof. Possover’s passion for teaching is at the heart of his work. Through the International School of Neuropelveology (ISNP), he trains surgeons from around the world in these advanced procedures. Every surgeon he educates becomes a multiplier of knowledge, capable of treating patients in regions far beyond his own reach.
This dedication reflects a philosophy that medicine’s greatest achievements are collective. A breakthrough is only meaningful if it can be shared, replicated, and improved upon by future generations.
Lessons for Medical Professionals and Entrepreneurs
This conversation is more than an inspiring personal story—it is a roadmap for anyone seeking to combine medicine, innovation, and business.
Clinical expertise can fuel entrepreneurship when paired with strategic thinking.
Patient awareness accelerates adoption, creating a powerful feedback loop between innovation and demand.
Education builds permanence, ensuring that treatments survive beyond the careers of their pioneers.
Whether you are a surgeon curious about entrepreneurship, a MedTech innovator looking for guidance, or a healthcare professional eager to create lasting change, Prof. Possover’s journey demonstrates that the skills learned in medicine—discipline, precision, and empathy—are the very qualities that can drive successful leadership.
In this podcast, Monir El Azzouzi and Prof. Marc Possover invite you to reflect on the future of healthcare. Their discussion shows that true medical progress lies not only in discovering new treatments, but also in ensuring that knowledge is shared, patients are informed, and innovations continue to thrive long after their creators have left the stage.
Links
INSP Link: https://isnp.possover.com/index
neurogyn: https://neurogyn.com/
Possover: https://www.possover.com/en/
Youtube: https://www.youtube.com/results?search_query=marc+possover
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
bersecurity in Medical Devices – A QA/RA Perspective
Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals for evidence.
In this article (based on the podcast episode), we explore:
How to prepare cybersecurity documentation for audits and inspections
Building post-market processes for vulnerability handling and reporting
Linking cybersecurity with standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001…)
Managing supplier and open-source component risks
Implementing and maintaining an SBOM
Key trends like the NIS2 Directive and the EU AI Act
👉 We finish with a practical checklist for QA/RA teams to assess their readiness today.
Cybersecurity isn’t about perfection—it’s about showing regulators you are in control.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Medboard
EUROPE
Guidance on the implementation of the Master UDI-DI - MDCG 2024-14 - rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf
Updated - Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
There's a significant backlog: far more applications submitted than certificates issued, especially for IVDs.
Time for certification: between 13 to 18 months on average
Delay due to application missing critical information and refusal due to submission outside NB scope
No transparency on capacity
Germany new radiation protection regulation - Start July 1st, 2025: https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Strahlenschutz/_artikel.html?nn=986770If device emit radiation and need clinical investigation in germany:
Include a radiation risk assessment in your clinical investigation dossier
Coordinate with Radiation protection authorities
Update investigator brochure and patient information
Stricter Monitoring & Reporting
Impact on Timelines
So stricter documentation, more authorities involved and longer approval times
UK
MHRA launches Route B notification pilot Clinical trials regulations rollout: https://www.gov.uk/government/news/mhra-launches-route-b-notification-pilot-as-part-of-clinical-trials-regulations-rollout - https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device
Switzerland
New in Swissdamed - Medical Device registration with UDI Device Module: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-mepprodukte-moeglich.html
1 july-2026
Magazine
Easy Medical Device Mag - Your QA RA Magazine: https://mailchi.mp/easymedicaldevice/emdmag1
Podcast:
Best 40 Medical Device Podcast - Thanks: https://www.millionpodcasts.com/Medical-Device-podcasts/
REST OF THE WORLD
SaMD and/or Artificial Intelligence on the spotlight - All countries want their regulation on it:
USA: PCCP - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
SFDA: Workshop September 9th: https://www.sfda.gov.sa/en/workshop/4387139
TGA: Understanding regulation of software-based medical devices: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices#samd-and-ai-medical-device-compliance
SAHPRA: Regulatory Requirements of AI/ML: https://www.sahpra.org.za/document/regulatory-requirements-of-artificial-intelligence-and-machine-learning-ai-ml-enabled-medical-devices/
Medical Device or Wellness device - Choose your side: https://www.sfda.gov.sa/sites/default/files/2025-08/MDS-G027.pdf
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA) in the medical device industry. But what does this mean for compliance professionals? Is AI a powerful tool to accelerate regulatory processes, or a risky shortcut that could jeopardize compliance?
In this new episode of the Medical Device Made Easy Podcast, Monir El Azzouzi sits down with RJ Kedziora (Estenda) to explore the opportunities and risks of using AI in regulatory compliance. Together, they discuss:
Why more QA/RA teams are experimenting with AI tools like ChatGPT, Gemini, Claude, and Grok
How to integrate AI into different product design and regulatory phases
The role of Prompt Engineering and why it matters in compliance
Practical tips for creating effective AI prompts
The warnings and risks you should keep in mind when relying on AI
How agencies like the FDA are beginning to explore AI for dossier reviews
👉 If you want to stay ahead in the world of medical device compliance, this conversation is a must-li
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Managing Software Updates in Medical Devices: Best Practices & Pitfalls
In the world of medical devices, software updates are never just technical tweaks—they directly impact patient safety, regulatory compliance, and product reliability. Managing these updates correctly is a challenge many manufacturers face, especially with evolving standards like ISO 13485 and IEC 62304.
In this episode of our podcast, we dive into the critical aspects of software update management for medical devices:
Versioning strategies – How to classify bug fixes, minor updates, and major releases, and the role of semantic versioning in regulated environments.
Documentation & traceability – Why proper version control and documentation are essential for audits and compliance.
Communication with stakeholders – Best practices for release notes, change logs, and informing users, regulators, and internal teams.
Common pitfalls – Mistakes that lead to compliance risks and how to avoid them.
Pro tips & resources – Actionable recommendations to strengthen your update and versioning strategy.
Whether you are a software engineer, QA/RA professional, or regulatory affairs manager, this episode will give you practical tools and insights to build a robust, compliant, and audit-ready update process.
👉 Listen now and discover how to master the balance between innovation, safety, and compliance in medical device software.
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
From Zero to One: Mastering Client Collaboration in Consulting
Starting your consulting journey can feel overwhelming—finding clients, building trust, and delivering results all at once. In my conversation for the Medical Device Made Easy podcast, I share my personal path: from my early days in engineering to creating Simply Medica, and the lessons learned along the way.
We discuss how to:
Build credibility before calling yourself a consultant
Turn your first project into a stream of referrals
Use networking (both in-person and online) to grow
Balance expertise with passion to create real impact
For anyone starting out—or looking to strengthen client relationships—this is your roadmap from zero to one.
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Have you ever wondered what it’s really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I sit down with Adam Isaac, an industry expert who made the leap from engineering student to successful entrepreneur in the MedTech world.
Adam’s journey is a masterclass in career transformation. Without prior experience in Regulatory Affairs & Quality Assurance (RAQA), he navigated the complex world of compliance and built a thriving consultancy business — all without traditional advertising.
What you’ll discover in this episode:
📈 How Adam transitioned into RAQA with no previous background
✅ The real day-to-day life of an ISO 13485 auditor — separating myths from reality
⚠️ Common mistakes consultants and auditors should avoid
🤝 What clients truly value when hiring a consultant
🚀 How to grow your consulting business organically
🤖 Adam’s next big step: creating an AI-powered audit tool to transform compliance work
Whether you’re just starting your career in medical devices or thinking about launching your own consultancy, this episode offers honest, practical insights you won’t find in any textbook.
🎧 Listen now and gain a realistic perspective on what it takes to succeed in the highly regulated MedTech industry.
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs (QA/RA). If you're a hiring manager, candidate, or aspiring recruiter in the life sciences or medtech industries, this episode is packed with honest insights and practical advice.
What you’ll learn:
Why Mitch chose to specialize in QA/RA
The tension between client expectations and candidate realities
How recruiters make their revenue (yes, we ask the money question!)
Whether promoting open positions is still a challenge in 2025
Mitch’s personal journey—education, family, and the struggles of building a business from scratch
What he would do differently if he had to start again
Whether you're considering using a recruiter or dreaming of launching your own hiring firm, this episode will help you understand what it really takes to go "from zero to one."
👉 Listen now and subscribe to our podcast to never miss a new episode!
Linkedin: https://www.linkedin.com/in/mitchrobbins/
Website: https://theanthonymichaelgroup.com/
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices
On July 16, 2025, a pivotal regulatory update—EU 2025/1234—comes into effect, expanding the use of electronic Instructions for Use (eIFU) to a much broader range of medical devices and accessories. Unlike previous regulations that limited eIFU to implantables or certain fixed devices, this amendment now authorizes the use of eIFU for all professional-use medical devices, including those covered by transitional provisions and even non-medical products listed under Annex XVI.
This shift marks a turning point in the digitization of compliance documentation in the medical device industry. In this video, we walk you through the full impact of the new regulation, as well as the operational benefits and responsibilities that come with adopting eIFU.
🔎 What the regulation says:
Manufacturers are allowed to provide eIFUs for professional-use devices, as long as the device is not likely to be used by laypersons.
For any device that might be used at home or by a non-professional, a paper IFU is still mandatory.
All versions of an eIFU—current and obsolete—must be hosted securely and remain accessible to authorities on request.
The URL of the eIFU must be registered in EUDAMED's UDI database once that requirement becomes mandatory.
📌 Top 5 reasons why switching to eIFU makes sense:
Broader regulatory permission
This update grants manufacturers the freedom to digitize IFUs across their entire product line, simplifying regulatory planning and execution.
Significant cost savings and faster updates
With eIFUs, there’s no need for printing, translation management across packaging batches, or physical distribution—everything can be updated instantly online, cutting costs and time-to-market.
Improved traceability and audit readiness
Digitally managing eIFUs ensures version control, easy access for auditors, and a clean digital trail that supports internal QA systems.
Better experience for healthcare professionals
Healthcare professionals prefer electronic formats for their speed, searchability, and multilingual options—making your devices more user-friendly.
Alignment with the EU’s digital vision
By linking eIFUs directly with EUDAMED and UDI databases, you align your business with the evolving regulatory ecosystem and future-proof your documentation process.
🛑 But eIFU is not a one-size-fits-all solution. You still need paper IFUs in key scenarios:
If your device could be used by laypersons, you must provide a paper version.
In low-connectivity settings, such as field hospitals or rural clinics, physical IFUs may be more reliable.
Adopting eIFU requires full platform readiness, including hosting, backups, multilingual versions, and internal QA validation.
Regulatory responsibility is now entirely on the manufacturer—including website uptime, version archives, and EUDAMED linkage.
Some stakeholders—including auditors and hospitals—still prefer traditional paper documentation, which could delay full adoption.
📽️ Watch our video to get a complete overview of the regulation and see how EasyIFU helps you implement a compliant, secure, and future-ready eIFU process. This is essential for RA/QA teams, product managers, and any manufacturer operating under MDR.
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Background: From IT in India to MedTech in Norway
You have a pretty fascinating background – you studied computer applications/IT back in India and now you’re a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?)
What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon?
And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?)
Day-to-Day as a QARA Manager
Let’s talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?)
It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine?
We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic?
On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding?
(For example, is it challenging that the scope is so broad – one moment you’re deep in engineering specs, next moment you’re updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?)
First MedTech Role at Hy5Pro AS
Let’s dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands?
(Feel free to explain what Hy5Pro’s product was and your role there, e.g. implementing the quality system, getting certifications, etc.)
Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that?
(e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.)
Leading QARA at RemovAid AS
After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role?
RemovAid’s product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale.
(We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!)
On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)?
RemovAid is in women’s health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it’s about making contraceptive care easier – that’s quite impactful.)
Consulting Experience at LINK Medical
Now, currently you’re working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company?
I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company’s project mid-stream.
Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you’ve learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)*
Diversity and International Career Insights
I’d like to touch on diversity and your international experience. You’re a woman in the medtech industry and you’ve built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you’ve noticed working in Norway compared to India?
The medtech industry, especially in leadership, still isn’t very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career?
What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.)
Rapid-Fire Round
Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I’ll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go!
Question 1: What’s one thing about your job that most people would be surprised to learn?
Question 2: What’s the coolest medical device or gadget you’ve worked on or seen so far?
Question 3: Are you team coffee or tea? (What fuels your workdays?)
Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)?
Question 5: If you weren’t in QARA, what alternate career could you see yourself in?
Question 6: What’s one Norwegian word or phrase you’ve picked up that you love to use? (Bonus: translate it for us!)*
Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!)
(Guest gives rapid-fire answers with laughter and brief commentary.)
Advice and Closing
Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect?
(For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.)
And maybe equally important, what should they not be scared of? People might think “Oh, I’m not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation?
Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital)
Welcome & Setup
Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager?
Career Journey
How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway?
What motivated you to switch into medical device regulations, and what were the biggest initial challenges?
In what ways has your IT background helped you excel in QARA?
Day-to-Day Responsibilities
What does a typical day or week look like for you as a QARA Manager?
Which tools or software (QMS systems, document controls, etc.) do you rely on most?
Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it’s all paperwork?
Which aspects of QARA do you find most challenging, and which are the most rewarding?
Hy5Pro AS Experience
What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand?
Can you share a memorable “learning moment” or funny anecdote from your time there?
RemovAid AS Experience
At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities?
Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it.
Any unexpected or humorous challenges you overcame in that role?
How did working on a women’s health product impact you personally?
LINK Medical Consulting
How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions?
What’s a standout project or recurring compliance issue you help clients solve?
How do you stay organized when juggling multiple clients and deadlines?
Diversity & International Insights
As a woman in medtech QARA, have you faced any unique challenges or opportunities?
What cultural adjustments did you experience moving from India to Norway?
How can medtech teams become more inclusive, especially in QA/RA?
Rapid-Fire Round
(Answer quickly with the first thing that comes to mind.)
One surprise fact about your job?
Coolest device or gadget you’ve worked on or seen?
Favorite (or funniest) QARA acronym—what does it mean?
Alternate career you might have chosen?
Norwegian word or phrase you love—translate it for us!
If your career were a movie title, what would it be?
Closing Advice
What practical steps should students or career-changers take to break into QARA?
What misconceptions shouldn’t they be afraid of when considering this field?
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Guest: Stefan Bolleininger
Title: From Zero to One: Creating your Consulting Firm
Logo: Be on Quality
Telling the story behind Be on Quality,
the challenges for you,
the way you did grow the business,
the things you would do differently
cost
Sharing also the life of a CEO that did start this project.
How many hours are you working,
is it easy to disconnect,
what are your fears.... AI
What’s next for Be on Quality
Link:
Be on Quality: https://www.be-on-quality.com/
Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
Quick recap
Stefan shared his entrepreneurial journey from working in automotive quality management to founding and growing his medical device consulting company, which was later acquired by a French engineering firm and merged with his sister company in Switzerland. Through discussions with Monir about his business experiences, they explored topics including customer relationships, pricing strategies, and the challenges of managing company growth while maintaining quality and communication. Stefan emphasized the importance of taking risks, maintaining industry connections, and leveraging technology while emphasizing the value of human interaction in their field, particularly in the context of his company's recent acquisition and expansion.
Next steps
Stefan to continue leading Be on Quality through the merger with Volker group.
Be on Quality team to expand services, particularly in AI implementation for medical devices and clinical trial areas.
Stefan to maintain transparent communication with employees regarding company changes and future plans.
Be on Quality to collaborate with sister company Be on Conception in Switzerland on combination products.
Stefan to continue balancing work responsibilities with personal time, including occasional “beach visits”.
Stefan to maintain regular revenue and project load calculations to mitigate fears about project availability.
Stefan to focus on providing value and mentorship to senior consultants and business area leads.
Be on Quality team to continue using AI as a tool to enhance work efficiency without replacing human expertise.
Summary
Journey to Medical Device Consulting
Stefan shared his journey from working in automotive quality management to founding his own medical device consulting company, Be on Quality GmbH, after being encouraged by his mentor. He described how he grew the business through referrals and local connections in Nuremberg, where there are approximately 500 medical device companies. Stefan emphasized that taking risks is essential for growth, particularly when transitioning from freelance work to company ownership, and noted that his supportive wife's encouragement was crucial since he was the first entrepreneur in his family.
Customer Retention Strategies in Medical Devices
Stefan emphasized the importance of maintaining connections and visibility in their industry, highlighting that cold calling and direct knocking do not work effectively. He shared experiences of past customer relationships, including a challenging project where deliverables did not meet the client's expectations, leading to a contract that could not be salvaged. Stefan stressed the need for clear communication and alignment with customer expectations to ensure long-term customer retention, which is crucial in their competitive medical device regulatory market. Monir suggested a mechanism for filtering potential customers with a small initial project to assess compatibility and expectations, which Stefan acknowledged as a useful approach, especially for startups and small companies.
Business Growth and Team Dynamics
Stefan discussed his business challenges, including a difficult working relationship with a former colleague that led to a split, but emphasized that such challenges are part of growing a company. He reflected on how his company, which started in 2017 and began as a freelance business in 2013, has grown to 27 employees, with his team sometimes advising him to focus on organic growth rather than taking on new projects. Stefan noted that while MDR hasn't significantly accelerated his business, he finds working with technology and engineering companies most comfortable, though his team has expertise across various product types.
Client Pricing and Documentation Insights
Stefan and Monir discussed pricing challenges with clients, where Stefan noted that while some clients negotiate prices, none have shown negative emotions about pricing. They also discussed the high costs of notified bodies and the importance of creating high-quality technical documentation to reduce review rounds. Stefan shared his perspective as CEO of Be on Quality, revealing he works approximately 50 hours per week and enjoys his job, though he prefers the concept of office time and home time rather than work-life balance.
AI's Role in Human Work
Stefan shared his professional journey, particularly in housing and installation projects, and expressed concerns about the evolving nature of his role as the company grows. He acknowledged his fear of not being able to provide sufficient mentoring to his colleagues, despite his efforts to maintain a hands-on approach. Stefan also discussed his perspective on artificial intelligence, emphasizing its potential to enhance rather than replace human work, and highlighted the importance of human interaction in their industry. Monir encouraged Stefan to view AI as a tool to assist and inspire, rather than relying on it systematically for all tasks.
Strategic Company Acquisition Success
Stefan discussed the recent acquisition of his company by a larger partner, which he described as a strategic move to expand services and reach. He emphasized that the decision was made after thorough discussions with his team, who supported the merger despite initial concerns about changes. Stefan highlighted the importance of trust and open communication within the company, which he believes contributed to the successful transition. The acquisition has allowed his company to grow and make a bigger impact, with additional resources and expertise from the partner company.
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Medboard: https://www.medboard.com/
EUROPE
new eIFU rules - Let's save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj
https://health.ec.europa.eu/latest-updates/commission-simplifies-instructions-use-medical-devices-further-digitalise-healthcare-systems-2025-06-25_en
EasyIFU.com
MDR + IVDR + AI Act = MDCG 2025-6 - Any other legislation to add?: https://health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en?filename=mdcg_2025-6_en.pdf
MDCG 2025-5: IVDR Performance Study - Masterclass to understand Performance Study: https://health.ec.europa.eu/document/download/f22f559b-dee5-43b4-9595-3ccdcca9f7ad_en?filename=mdcg_2025-5_en.pdf
Team-NB. Software Qualification (IVDR) clarification - Translation of the MDCG 2019-11: https://www.team-nb.org/wp-content/uploads/2025/06/Team-NB-PositionPaper-Software-Qualification-under-the-IVDR-V2-20250627.pdf
MDCG 2019-11: https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=mdcg_2019_11_en.pdf
CECP: Mechanical Respiratory - Result is not good: https://health.ec.europa.eu/document/download/80f2432d-a9da-48ae-8ebb-0054b4922033_en?filename=cecp-2025-0000232089_opinion_en.pdf
MDCG 2025-4 Software delivered with Online Platforms - Are your apps conform: https://health.ec.europa.eu/document/download/ec9b0f40-7f82-43a7-b833-ebd45b772eae_en?filename=mdcg_2025-4_en.pdf
PROJECT NAME: COMBINE - Clinical Trials with Medicine and IVDs: https://ec.europa.eu/newsroom/sante/newsletter-archives/64447
https://health.ec.europa.eu/medical-devices-topics-interest/combined-studies/combine-project-1-pilot-all-one-coordinated-assessment_en
UK
UK PMS mandatory since June 16th, 2025 - Learning starts: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements#full-publication-update-history
Press Release: https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain
Periodic Safety Update Report: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur
Example of reportable incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents
MORE Guide update: https://assets.publishing.service.gov.uk/media/6847fc9c944a600f13bcb852/User_Reference_Guide___MORE_Incident_Submissions.pdf
Document for implementation of Data: https://www.gov.uk/government/publications/documentation-for-implementation-of-data-requirements-under-the-new-post-marketing-surveillance-regulations
ROW
USA
UDI for combination products - What are the rules?: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identifier-requirements-combination-productsConducting Remote Reg Assessment - SQuestion and Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers
Transfer of Premarket Notification (510k) - Questions & Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transfer-premarket-notification-510k-clearance-questions-and-answers
CANADA
Canada is cancelling all MDELs - Only if you don't confirm the Annual License Review: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/cancellation-non-compliance-annual-review-requirements-2025.html
Saudi Arabia
SFDA Webinar: Risk Management File - July 8th, 2025 10 AM Saudi Time: https://www.sfda.gov.sa/en/workshop/3868398
Podcast
Episode 340 - Software as a Medical Device: Beginner's guide to Testing and Validation: https://podcast.easymedicaldevice.com/340-2/
Episode 341 - Notified Bodies raise concern on Risk Grading: https://podcast.easymedicaldevice.com/341-2/
Episode 342: From Zero to One: SaaS Founder's First Five Years: https://podcast.easymedicaldevice.com/342-2/
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
From Zero to One: SaaS Founder's First Five Years with Ivan Perez Chamorro 🎧💡
In this exciting episode of the Easy Medical Device Podcast, we welcome Ivan Perez Chamorro, the CEO and founder of Medboard, a fast-growing SaaS company. Ivan takes us behind the scenes of his entrepreneurial journey, from starting with zero to building a thriving business in the tech world. 🚀
In this candid conversation, Ivan dives into:
The story behind Medboard and how it all began from scratch 🛠️
The challenges he faced along the way and how he successfully scaled the business 📈
The lessons learned and the things he would do differently if given a second chance 🤔
A day in the life of a CEO: How many hours does Ivan work? How does he disconnect? 🤯
The personal fears and struggles that come with being a founder, and how to overcome them 😬
And of course, what’s next for Medboard—the exciting plans ahead! 🔮
This episode offers an honest, no-holds-barred look at the journey of building a successful SaaS company and what it takes to lead with passion, persistence, and resilience.
Don't miss this insightful discussion! Tune in now and hear firsthand what it takes to take a business from zero to one.
Listen to the full episode here: Medboard
Social Media to follow
ivan-perez-chamorro linkedin: https://www.linkedin.com/in/ivan-perez-chamorro/
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does
Risk Management mistakes that could cost you your certification!
In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi tackles one of the most common and preventable Notified Body non-conformities: flawed risk grading strategies.
If your team is still using overcomplicated matrices or adjusting severity post-mitigation — this episode is your wake-up call.
What you’ll learn:
- The most frequent audit findings related to risk grading
- Real-world case studies showing where manufacturers got it wrong
- A clear step-by-step guide to build a compliant and logical matrix
- How to use ISO 14971 & ISO/TR 24971 correctly
- Why severity should NEVER be downgraded after controls
We’ll also cover:
- How to scale your matrix by device class
- Common pitfalls to avoid
- How to align QA, RA, clinical, and engineering teams
- How Easy Medical Device can help you fix or build your Risk Management system
Whether you’re in Regulatory Affairs, Quality Assurance, R&D, or Clinical, this episode will give you concrete tools to strengthen your risk files and pass your audits with confidence.
Watch now and share it with your team!
Need help? Contact Easy Medical Device to review or improve your Risk Management File.
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Notified Bodies raise concern on Risk Grading appeared first on Medical Device made Easy Podcast. hamza benafqir
Learn how to turn user needs into clear, beginner-friendly test plans for Software as a Medical Device (SaMD). In this episode, we break down the essentials of SaMD validation—no PhD required! We cover:
- Why testing matters: Real-world examples of what can go wrong (and how to avoid it)
- From user needs to test cases: Simple “if-then” steps you can try today
- Who should test: Pros and cons of in-house vs. external testers
- eQMS basics: How to validate your electronic Quality Management System with minimal hassle
- Quick tips: The one thing you must do first, and the top beginner pitfall to avoid
Whether you’re a developer, QA engineer, or healthcare innovator, you’ll walk away with practical strategies to ensure your medical software is safe, reliable, and compliant. Tune in and make your next SaMD project a success!
Link* Anindya Mookerjea: https://www.linkedin.com/in/anindyamookerjea * S-Cube Technologies: https://eqms-smarteye.com/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Software as a Medical Device: Beginner’s Guide to Testing & Validation appeared first on Medical Device made Easy Podcast. hamza benafqir
Europe* Notified Body survey report – 31 October 2024 – What is the main Surprise: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf * The MIR form has been updated – Version 7.3.1 – Don’t use previous versions: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en
UK* UK MIR and FSCA – Change is in the AIR: https://www.gov.uk/government/publications/more-implementation/gb-mir-and-fsca-schema-implementation-guide * UK MDR 2002 is dying – Long life to UK MDR 2025: https://www.legislation.gov.uk/ukdsi/2025/9780348269529 * : Real-World Data or Clinical Trial or Both?- This is the question: https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions
Training* EU MDR Green Belt June 2025 – June 23rd, June 27th: https://school.easymedicaldevice.com/course/gb34/ * eTraining on Vigilance and Audit preparation – Self-paced: https://school.easymedicaldevice.com/emd-course
ROWUSA* Q-Sub update – New electronic template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-q-submissions
Brazil* SIUD or UDI in Brazil – Manual of Use in Portuguese: https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/manual_siud_v01.pdf
Saudi Arabia* Series of Webinar – June is a Busy month in Saudi Arabia: + 16 June 2025 Companion Diagnostic Regulatory Requirements: https://www.sfda.gov.sa/en/workshop/3540492 + 17 June 2025 Saudi Unique Device Identification (SAUDI-DI): https://www.sfda.gov.sa/en/workshop/3540493 + 19 June 2025 Artificial Intelligence and Machine Learning: https://www.sfda.gov.sa/en/workshop/3540495 + 23 June 2025 Digital Health Medical Devices regulatory approach: https://www.sfda.gov.sa/en/workshop/3540496 + 24 June 2025 Medical Devices Risk Classification: https://www.sfda.gov.sa/en/workshop/3540497 * Saudi In-house Devices – Not like EU: https://www.sfda.gov.sa/sites/default/files/2025-05/MDS-G022En.pdf
Turkey* In Turkey, Economic Operators are Liable – Even after discontinuation or temporary stop of supply: https://titck.gov.tr/duyuru/tibbi-cihazlarin-tedarikinin-kesintiye-ugramasi-veya-durdurulmasi-sona-ermesi-durumunda-i-ktisadi-i-sletmecilerin-yukumlulukleri-hakkinda-duyuru-21052025113350
PODCAST* Podcast Nostalgia – What happened in May 2025 + Episode 334 – What is the new UK Post-Market Surveillance Requirements? With Claire Dyson: https://podcast.easymedicaldevice.com/334-2/ + Episode 335 – When is Regulatory Affairs needed during Design? With Aouda Ouzza: https://podcast.easymedicaldevice.com/335-2/ + Episode 336 – is EHDS dangerous for Medical Device Manufacturers? With Cecile van der Heijden: https://podcast.easymedicaldevice.com/336-2/ + Episode 337 – How Deepeye Medical overcame the AI Act? With Carmen Bellebna; https://podcast.easymedicaldevice.com/337-2/ + Episode 338 – Trapped or Strategic? Changing Notified Bodies During MDR transition: https://podcast.easymedicaldevice.com/338-2/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News JUNE 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video* Linkedin Post: https://www.linkedin.com/feed/update/urn:li:activity:7331974765156384769/ * Team NB position paper transfer agreement: https://www.team-nb.org/wp-content/uploads/2025/01/Team-NB-PositionPaper-TransferAgreement-v02-20240702-with-instructions.pdf * MDCG 2022-4: https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-4_en.pdf
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Trapped or Strategic? Changing Notified Bodies During MDR Transition appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification.
Who is Carmen Bellebna? Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye’s QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Carmen Bellebna LinkedIn: https://www.linkedin.com/in/men-be-a1828a81/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice * Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
The post How deepeye Medical overcame the AI ACT? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. We will talk about the impact on Medical Device manufacturers but also on you as a human being as all this is about manipulation of data. Personal data or anonymized data. But can it be un-anonymized… Listen to this episode.
Who is Cecile van der Heijden? Cécile van der Heijden is a senior legal expert at Axon Lawyers, a boutique law firm based in the Netherlands specialized in legal and regulatory affairs for the life sciences sector. With a strong focus on digital health, data protection, and medical device law, Cécile advises companies on navigating complex European regulations such as the MDR, GDPR, and the newly adopted European Health Data Space (EHDS) Regulation. She regularly supports clients developing AI, software as a medical device (SaMD), and connected technologies, helping them align innovation with compliance. Known for her practical approach, Cécile frequently speaks at conferences and publishes insights on digital health law across the EU.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Cecile van der Heijden LinkedIn Profile: https://www.linkedin.com/in/cevanderheijden/ * Axon Lawyers website: https://www.axonlawyers.com/ * EHDS: https://www.european-health-data-space.com/ * Article EHDS: https://www.consilium.europa.eu/en/press/press-releases/2025/01/21/european-health-data-space-council-adopts-new-regulation-improving-cross-border-access-to-eu-health-data/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice * Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
The post Is EHDS dangerous for Medical Device manufacturers? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we’ll let you know when and why you should involve them earlier. Listen to this episode.
Who is Aouda Ouzzaa? Aouda Ouzzaa brings over 16 years of expertise in Regulatory Affairs (RA) and Quality Assurance (QA), supporting the entire product lifecycle—from development to post-market surveillance. She has successfully led projects across pharmaceuticals, biologics, medical devices (EU MDR), cosmetics, and Software as a Medical Device (SaMD).
Her global regulatory knowledge spans EMA, FDA, GCC, and Rest of World (ROW) markets. Aouda has hands-on experience preparing IND, BLA submissions, and securing orphan drug designations.
As a certified GMP and GDP auditor, Aouda has worked closely with cross-functional teams to ensure compliance with international standards while optimizing regulatory interactions. Her methodical approach and deep understanding of complex regulatory environments make her a strategic asset for organizations navigating global compliance challenges.
Whether you’re developing a new drug, launching a medical device, or scaling a digital health solution, Aouda Ouzzaa brings the insight and precision needed to achieve regulatory success.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Aouda Ouzza LinkedIn Profile: linkedin.com/in/aouda-ouzzaa-51877a32 * SmartQARA website: https://smartqara.com/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice * Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
The post When is Regulatory Affairs needed during Design? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. You have maybe heard recently the UK MHRA saying that there should be a new requirement to perform Post-Marketing Surveillance for Medical Devices in the UK. So what this means? Who is impacted? How to comply? Listen to this episode.
Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body offering ISO 13485, MDSAP and CE conformity assessment to medical device manufacturers. She is involved in DQS’s application to become a UK Approved Body and offer UKCA conformity assessment. In parallel, she interacts with DQS’s international team developing accessible content to support manufacturers with the regulatory pathways and transitions.
Who is Monir El Azzouzi?Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. –
Links from the Video * Claire Dyson LinkedIn: Claire Dyson | LinkedIn * Blogs – 3 part series on U vs UK PMS * UK PMS Regulations: Overview & Key Requirements for Medical Device Safety * UK Medical Device Vigilance – Part 2: Vigilance & Reporting Requirements * UK PMS vs EU MDR – Key Differences & Impact on CE-Marked Medical Devices
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice * Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
The post What is the new UK Post-Market Surveillance Requirements? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. You will see in this episode that some elements will be similar to registration in EU or US but you will also see a lot of differences. We will also talk about cost for the registration and you will see how this is affordable.
Who is Adam Isaacs Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Adam Isaacs Rae LinkedIn: https://www.linkedin.com/in/adam-isaacs-rae/ * https://theotherconsultants.substack.com/p/register-your-medical-device-in-malaysia
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to register your Medical Device in Malaysia? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Yassine Bader will explain to you the advantage or the risk of quitting your permanent job to become a consultant. You will see within this episode that this is not something made for everyone, so you really need to listen to this to understand if this is the right decision for you.
Who is Yassine Bader? Coach expert en transition de carrière et leadership, Yassine Bader cumule plus de 15 ans d’expérience au cœur de l’industrie (automobile, chimique, dispositifs médicaux, transport, pharmaceutique et agroalimentaire), accompagnant avec succès plus de 100 cadres vers une indépendance entrepreneuriale inspirante et un leadership d’excellence. Son approche : pragmatique, percutante, tournée vers l’action et les résultats concrets. Créateur du guide gratuit et fondateur du programme ManagerImpact, il équipe les managers d’outils précis et immédiatement exploitables pour devenir des leaders alignés, confiants et reconnus. Très prochainement, il dévoilera un séminaire exclusif destiné aux cadres industriels décidés à franchir le pas vers le consulting et le management de transition freelance, en leur fournissant toutes les clés indispensables pour réussir avec confiance leur nouvelle vie professionnelle.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Yassine Bader LinkedIn: https://www.linkedin.com/in/yassine-bader-yab/ * Programme Yassinebader: https://programme.yassinebader.com/manager-impact
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Should you quit your job to become a consultant? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. We will review the US and EU requirements and provide you a list of legislation and standards you should look at. Cyrille will also share his experience related to the reviews done by a Notified Body and an FDA.
Who is Cyrille Michaud? Co-founder and managing partner of MD101 Consulting.
Consultant in Quality Assurance and Regulatory Affairs for software in medical devices and software as medical devices.
Specialties: Software Processes Management.
CE Mark & FDA 510k
21 CFR 820 – ISO 13485 – ISO 14971 – IEC 62304 – IEC 62366 – IEC 60601 – IEC 82304-1 – UL 2900-1 – IEC 81001-5-1
Agile Methods applied to medical device software design.
Cybersecurity applied to medical devices.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Cyrille Michaud LinkedIn: https://www.linkedin.com/in/cyrillemichaud/ * MD101 : www.MD101.io * Trainings on Cybersecurity : https://blog.cm-dm.com/pages/Medical-Device-Software-Trainings * Blog post sur cyber et normes : https://blog.cm-dm.com/post/2023/10/06/Final-2023-FDA-Premarket-Cybersecurity-guidance-released * FDA resources on cybersecurity : https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity * IG NB checklists : https://www.ig-nb.de/veroeffentlichungen (page in German but download links in the page are in English) * Standard IEC 81001-5-1 and 81001-5-2: https://blog.cm-dm.com/post/2024/10/04/IEC-81001-5-2%3A-AAMI-SW96-cousin-and-IEC-80001-5-1-sister * Blog IEC 81001-5-1: https://blog.cm-dm.com/post/2024/02/23/IEC-81001-5-1-Right-Here-Right-Now
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to satisfy Cybersecurity for FDA and EU? appeared first on Medical Device made Easy Podcast. hamza benafqir
Sponsor: MedboardEurope* Certificates under Condition – Team NB press release: https://www.team-nb.org/wp-content/uploads/2025/03/PressRelease-WP3-Task3.3-Certificates-with-Conditions-20250312.pdf * European Artificial Intelligence Office -A new expert panel for AI Medical Devices: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500454 * UK invented the AIaMD – Fewer law but more guidance: https://www.gov.uk/government/publications/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-rhc/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-regulatory-horizons-council * Submit a Clinical Study in Spain and Belgium – Each country decides: + Spain: https://www.aemps.gob.es/informa/la-aemps-detalla-el-procedimiento-para-la-publicacion-de-informes-de-investigaciones-clinicas-con-productos-sanitarios-en-espana/ + Belgium: https://www.afmps.be/sites/default/files/Guideline%20Submission%20of%20Clinical%20Investigation%20according%20to%20MDR_version%2011.0_0.pdf * SCHEER – Brain Stimulators – Non-medical purpose use: https://health.ec.europa.eu/latest-updates/scheer-minutes-working-group-meeting-brain-stimulators-19-march-2025-2025-03-28_en * IMDRF Reliance Program – For Regulators but can impact manufacturers: https://www.imdrf.org/sites/default/files/2025-03/IMDRF%20Reliance%20playbook%20draft%20%28final%29.pdf * Successful Pilot Advice Expert Panel – For high-risk device: https://www.ema.europa.eu/en/documents/report/pilot-advice-expert-panels-manufacturers-high-risk-medical-devices-interim-report-experience-pilot-february-2023-december-2024_en.pdf * Team NB MDR Clinical Training – May 7th 2025: https://www.team-nb.org/wp-content/uploads/2025/03/Leaflet-MDR-Clinical-Manufacturers-Training-20250507.pdf
Registration* Ask Easy Medical Device for Registration – Support most of the world: https://easymedicaldevice.com
ROW* Sex Specific Data in Clinical Study – Do it or?: https://www.fda.gov/media/82005/download * Brazil UDI in Progress – Subtitle: Anvisa consultation is open: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-abre-consulta-publica-sobre-base-de-dados-para-identificacao-unica-de-dispositivos-medicos * Become a Conformity Assessment Body in Malaysia – Notified Body are not automatically Conformity assessment bodies: https://www.mda.gov.my/images/DOC%20UPLOAD/DOC%20UPLOAD%202025/Guidance%20Document%20Conformity%20Assessment%20Body%20CAB%20Guide%20for%20Conducting%20Conformity%20Assessment%20By%20Way%20of%20Verification.pdf * Saudi Arabia ISO 13485 guidance -Looks like an MDSAP structure: https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-G024.pdf * Singapore Cybersecurity Best Practice – Consultation until May 12, 2025: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-updates/best-practices-guide-on-medical-device-cybersecurity_draft-for-consultation.pdf?sfvrsn=8dcfa560_1
Podcast* Episode 328 – What are the TOP 3 FDA inspection issues with Darrin Carlson: https://podcast.easymedicaldevice.com/328-2/ * Episode 329 – What if the Notified Body asks you: Is your Software Validated?: https://podcast.easymedicaldevice.com/329-2/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News April 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Tibor Zechmeister will challenge us on what we would answer if the Notified Body asks if our software is validated. CSV or Computer System Validation will become one of the major topics So stay tuned.
Who is Tibor Zechmeister? Passionate about Creating Maximum Efficiency in MedTech Regulatory | Head of Regulatory and Quality Flinn.ai | Notified Body Auditor | MedTech Entrepreneur | Software Solutions for Regulatory Automation with AI
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Tibor Zechmeister LinkedIn: https://www.linkedin.com/in/tibor-zechmeister/ * Flinn.ai Website: https://www.flinn.ai/ * ISO 13485:2016 https://www.iso.org/standard/59752.html * ISO/TR 80002-2:2017: https://www.iso.org/standard/60044.html
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What if the Notified Body asks you: Is your Software Validated? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. We will also explain the different between an FDA inspection and a Notified Body audit. So stay tuned.
Who is Darrin Carlson? Darrin Carlson has over ten years of experience in Quality and Regulatory in the medical device, pharmaceutical, and combination product fields. In addition to his current role as a Regulatory Affairs Specialist, he also helps small MedTech companies stay compliant with AI-powered, human-driven internal audits and publishes the QA/RA Playbook, a free weekly newsletter helping subscribers simplify compliance, empower innovation, and advance their careers.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Darrin Carlson LinkedIn: https://www.linkedin.com/in/darrinlcarlson/ * Fix the Top 6 QMS Issues: https://qarasolutions.com/fixthetopsix * FDA page on Warning Letters: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters * FDA page on 483 data: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What are the TOP 3 FDA inspection issues? appeared first on Medical Device made Easy Podcast. hamza benafqir
Sponsor* Medboard: https://www.medboard.com/
Europe* Health Data Legislation – Manufacturers should comply: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500327&qid=1741166600030 + FAQ: https://health.ec.europa.eu/document/download/4dd47ec2-71dd-49fc-b036-ad7c14f6ed68_en?filename=ehealth_ehds_qa_en.pdf * eIFU proposal until March 21st- eIFU for professional user: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14470-Medical-devices-electronic-instructions-for-use_en * 14th Notified Body Under IVDR – Centro Nacional de Certification de Productos Sanitarios: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43640&filter=notificationStatusId:1 * Exceptional access of Non-CE Medical Devices – France simplified form: https://ansm.sante.fr/actualites/acces-derogatoire-pour-un-dispositif-medical-depourvu-de-marquage-ce-optimisation-du-processus-de-demande-a-lansm * EMA scientific Advice for High-risk device – Portal available: https://www.ema.europa.eu/en/news/ema-establishes-regular-procedure-scientific-advice-certain-high-risk-medical-devices + Guide: https://www.ema.europa.eu/en/documents/other/guide-manufacturers-procedure-requesting-advice-expert-panels-clinical-investigations-or-clinical-development-strategies-high-risk-medical-devices_en.pdf * IGJ on Generative AI in Healthcare – Be careful: https://www.igj.nl/zorgsectoren/medische-technologie/publicaties/publicaties/2025/02/10/igj-roept-zorgaanbieders-op-ga-zorgvuldig-om-met-invoering-van-generatieve-ai-toepassingen * Pilot for Clinical Investigation and Performance Study – 1 application for all member states: https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en + FAQ: https://health.ec.europa.eu/document/download/7ee00635-08dd-4c24-b892-74fc8eebfb54_en?filename=md_ci_pilot-ci-ps_faq_0.pdf + Participating member states: https://health.ec.europa.eu/document/download/e987dcf9-cc8c-44c4-b772-18919cd3f84c_en?filename=md_ci_pilot-ci-ps_ms-pilot-coordinated-assessment.pdf * What is an AI system – Read the guide: https://digital-strategy.ec.europa.eu/en/library/commission-publishes-guidelines-ai-system-definition-facilitate-first-ai-acts-rules-application
Switzerland* Swissmedic assessment on PMS – Result is BAD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/ueberpruefung-dokumentation-ueberwachung-nach-inverkehrbringen-smc.html
UK* IVD registration in the UK – Transition to IVDR: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market + EU IVDD Extension: https://www.gov.uk/government/publications/registration-of-in-vitro-diagnostic-devices-with-expiring-ce-certificates/registration-of-certain-in-vitro-diagnostic-devices * Reliance on Exention of CE- Reusable Class I devices : https://www.gov.uk/government/publications/registration-of-reusable-or-upclassified-class-i-devices-andor-expiring-ce-certificates/registration-of-certain-medical-devices-which-are-reusable-class-i-devices-upclassified-class-i-devices-andor-reliant-on-expiredexpiring-ce-certif#reliance-on-extended-certificates-in-great-britain-gb–
Webinar* 28 March – AI in Healthcare – EU priorities and Ecosystem Synergies: https://digital-strategy.ec.europa.eu/en/events/ai-healthcare-eu-priorities-and-ecosystem-synergies
Newsletter* Easy Medical Device Newsletter – Get fresh information: https://www.linkedin.com/posts/easymedicaldevice_medicaldevices-mdr-regulatorycompliance-activity-7304455925044531200-mKt0?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI * Medtech Leading Voice Newsletter – Reference a lot of Medical Device posts: https://www.linkedin.com/newsletters/medtech-leading-voice-6871913764770324480/
ROW* Australia: Ask consent if product not compliant – Not compliant to the Essential Principles: https://www.tga.gov.au/resources/resource/reference-material/consent-medical-devices-do-not-meet-essential-principles * South Africa: Classification rules – Some rules were updated: https://www.sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-MD-04_v5-Guideline-for-Classification-of-MD-and-IVDs.pdf * Application to Canada – Draft guidance: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses/draft-guidance-on-managing-applications-for-medical-device-licences-eng.pdf
Podcast* Episode 323 – The good, the bad and the ugly of certification bodies with Mark Rogovoi; https://podcast.easymedicaldevice.com/323-2/ * Episode 324 – How and who to build your Risk Management File with Bijan Elahi: https://podcast.easymedicaldevice.com/324-2/ * Episode 325 – FDA: Advantage of the Breakthrough Device Program with Michelle Lott: https://podcast.easymedicaldevice.com/325-2/ * Episode 326 – How to avoid Clinical Investigation for your Device with Hatem Rabeh: https://podcast.easymedicaldevice.com/326-2/
The post Medical Device News March 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations. There are also some confusion between Clinical Evaluation and Clinical Investigation. Let’s clarify all this and give you the right strategies for your Medical Devices. So stay tuned.
Who is Hatem Rabeh? Hatem Rabeh is a Medical Doctor with an MSc in Medical Engineering, specializing in clinical evaluation for medical devices.
With over 8 years of experience, he supports manufacturers in MDR compliance by preparing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Class I to Class III devices, including software, implants, and robotic systems. His expertise covers literature reviews, clinical strategy, and regulatory compliance.
Hatem also shares his knowledge through online training, consulting, and LinkedIn content.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Hatem Rabeh LinkedIn: https://www.linkedin.com/in/hatem-rabeh/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to avoid Clinical Investigation for your Device? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? Michelle will explain if you can be part of this and how to do it also. So stay tuned.
Who is Michelle Lott? Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Michelle Lott LinkedIn: https://www.linkedin.com/in/michellelottraqa/ * Company page : https://leanraqa.com/ * FDA breakthrough devices program guidances: https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post FDA: Advantage of the Breakthrough Device Program appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Bijan Elahi will share with us the methodology you should follow to start your Risk Management Project. On some of my consulting projects, I ask people if they can send me their Risk Management File, which usually follows by “I don’t have one” and then by “How can we create one?”. So Today Bijan Elahi who is an expert on risk management will explain the best way to start such project.
Who is Bijan Elahi? Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and an affiliate professor at Drexel University. Previously he served as the Medtronic corporate Advisor on safety risk management of medical devices. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA).
Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling medical book: Safety Risk Management for Medical Devices, published by Elsevier publishing.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Linkedin Page: https://www.linkedin.com/in/bijanelahi/ * Medtech Safety website: https://www.medtechsafety.com/ * Safety Risk Management for Medical Devices Book: https://www.amazon.com/Safety-Risk-Management-Medical-Devices-ebook/dp/B09M3QXNL9/ref * Conference website: https://medsafetyconf.net/home.php * Conference registration page (early bird discounts end on 28 February): https://medsafetyconf.net/registreren.php * Bijan’s email: bijan@medtechsafety.com
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How and Who to build your Risk Management File? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturers so this is really something that can show you the inside. You will see the good of working with them but also the bad. Mark will be really honest and share some stories, and you’ll see that this is not all good.
Who is Mark Rogovoi? Mark Rogovoi brings 18 years of international experience in Manufacturing Quality across Poland, Russia, Kazakhstan, Spain, and Israel. He is a seasoned QMS professional proficient in ISO 9001 and ISO TS 16949 standards, with a strong Lean 6 Sigma background as a certified Green Belt. As a Lead Auditor for ISO 9001, he has conducted both internal and external audits. Mark also holds an EMBA from the Stockholm School of Economics and a master’s degree in Electrotechnical Engineering from Saint-Petersburg State Electrotechnical University.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Mark Rogovoi LinkedIn: https://www.linkedin.com/in/markrogovoi/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post The good, the bad and the ugly of certification bodies appeared first on Medical Device made Easy Podcast. hamza benafqir
MedboardEU
- EU MDR and IVDR article 10a – Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a
- EU IVDR transition periods – Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdf
- EUDAMED
- EMDN: UPDATE or not to UPDATE – MDCG 2024-2 Rev 1 and 2021-12 Rev 1 :
- https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf
- MDCG 2024-2: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf
- MDCG 2021-12: https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf
- Contact points of National Authorities – Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf
- EU Battery 2023/1542 – Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214
- Swiss Maintenance of Medical Devices – Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/maintenance.html
- UK timeline for UKCA – Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf
- UK Post-Market Surveillance – Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation
- https://assets.publishing.service.gov.uk/media/67813b39363ac763c8ede498/Medical_devices_periodic_safety_update_report__PSUR__formatting__1_.pdf
- PMS Guidance: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-periodic-safety-update-reports
- PMS Requirements: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes
- PMS Obligations per device type: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type
- TUK Vigilance Reporting – Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents
- FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history
- Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation
- Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history
- Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses
- Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems
- UK guide for IVD – Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf
Training
- EU MDR training – Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/
Rest of the World:
- Laboaratory Developed Tests FAQ – Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests
- How to apply your dossier in Australia – Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment
- Malaysia guidance for HIV Self-test – Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file
- Import Medical Device for Personnal Use in Malaysia – What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file
- Alert by Philippines for Product registration – Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf
- Saudi Arabia clearance of Medical Devices – For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf
- China Medical Device Regulations Round-up 2024 – Cisema.com video: 2024 Round-Up of China Medical Device regulations
- India update classification lists – List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI=
Podcast
- Episode 318 – How to register a Medical Device in South Africa – Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/
- Episode 319 – How to perform your PMS for a Drug-Device Combination – Joan D’Souza: https://podcast.easymedicaldevice.com/319-2/
- Episode 320 – Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/
- Episode 321 – 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/
The post Medical Device News January 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, I will give you 6 tips to help you grow as a QA RA Manager. These are coming from my own experience so maybe they are not exactly reflecting your situation but this may help you understand some logic.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post 6 Tips to Grow as a QA RA Manager appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. He will go through all the clauses and for each of them he will bring his TOP issue. So after that the exercise will be for you to check if this issue can be identified within your QMS. So good research to you.
Who is Adam Isaacs Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Adam Isaacs Rae LinkedIn: https://www.linkedin.com/in/adam-isaacs-rae/ * Top ISO 13485 Nonconformances: https://easymedicaldevice.com/top-iso-13485-nonconformances-and-how-to-prevent-them/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post TOP 5 common NCs on an ISO 13485 audit appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. We will review what is a Drug-Device Combination or DDC and then identify some case studies. She will also provide us with the guidances that we should follow.
Who is Joan D’Souza? I have experience in pharmacovigilance, regulatory affairs, medical writing, and law (JD, licensed to practice law in the state of Minnesota, US). I offer future employers dedication, a passion for learning, and a longstanding insight into the pharmaceutical sector.
I am driven, hard-working, enthusiastic, and always willing to take on new responsibilities.
Therapeutic areas: vaccines, endocrinology, immunology, rare diseases, gastroenterology, autoimmune diseases, cardiovascular diseases, dermatology, medical devices, drug-device combinations, oncology, and neurology.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Joana de Souza LinkedIn: https://www.linkedin.com/in/drjoanswatidsouza/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to perform your PMS for a Drug-Device Combination? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will happen in a near future. She will also talk to us about the participation of South Africa to the AMDF – Africa Medical Device Forum, where pilot project started to issue a continental approval within 22 countries. So this may help register more easily in Africa.
Who is Khanyisile Nkuku? Ms Khanyisile Nkuku In her current role as a Medical device & IVD Registration Officer at the South Africa Competent Authority (SAHPRA) , she contributes her expertise in the assessment and registration of medical devices & IVD’s in South Africa to promote medical device & IVD access on a global scale, with a particular focus on African countries.
She holds a Bachelor of Pharmacy honours degree ,a Master’s in Pharmacy administration & Policy Regulation , and is currently busy with Masters in Business Administration in Healthcare Leadership .
She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening. Having great strength in policy advocacy, policy development, policy implementation and compliance.
She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF) technical mainly the MDA-TC ( Medical device Assessment Technical committee member. She is further a committee member for two South African Bureau of Standards (SABS) Technical committees .
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Khanyisile Nkuku LinkedIn: http://linkedin.com/in/khanyisile-nkuku-975663a9 * SAHPRA Website: https://www.sahpra.org.za/medical-devices/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to register a Medical Device in South Africa? appeared first on Medical Device made Easy Podcast. hamza benafqir
Stefan bolleininger will share with us information regarding Artificial intelligence and MDR.
This presentation happened during Medica 2024. So if you have any questions you can ask ok the comments.
Who is Stefan Bolleininger? Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
Link:
- Stefan bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Medica: AI & MDR FLIP THE COIN appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. He will explain the situation in Consulting, Representation, eQMS , eIFU project, Medtech Conferences, Podcasts Episodes, Topra Awards and all the future projects in 2025.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Easy Medical Device Great Summary 2024 appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. He will provide his advice so you can be successful and already know some issues that you may encounter as a Startup
Who is Adnan Asfaq? Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech, and Pharmaceutical industries. Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has been working with start-up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market and stay in the market.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:
- Adnan Ashfaq LinkedIn: https://www.linkedin.com/in/adnan-ashfaq-44478121/
- Simplimedica website: https://simplimedica.com
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What are the major pitfalls of Startups in Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
MEDBOARD: https://www.medboard.com/
EUROPE
- TEAM-NB high level position – Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf
- MDCG 2024-15 – Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdcg_2024-15_en.pdf
- EMA activities on Combination products – Reminder on Drug-Device assessment.: https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day- session-4-ema-activities-medical-devices_en.pdf
- MDCG 2024-16 Interruption or Discontinuation – For certain devices: https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en? filename=mdr_qna-article10a_mdr-ivdr_en.pdf and annex https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16 _annex_en.pdf
- Joint Paper from 9 Member states – Council of the European Union: https://data.consilium.europa.eu/doc/document/ST-15380-2024-INIT/en/pdf
- Reduction of Administrative Burdens
- Centralization of System Management to the EMA
- Predictable Certification Procedures
- Enhanced Coordination and Support
- Impact Assessment and Resource Allocation
- MDCG 2024-14 Master UDI-DI – Contact lenses: https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14 _en.pdf
- Master UDI-DI Assignment
- Labelling Requirements
- Vigilance Reporting
- EUDAMED Registration
- Implementation Timeline
- Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB: https://www.team-nb.org/wp-content/uploads/2024/11/Team-NB-PositionPaper-AI-in-MDQuestionnaire-V1-20241125.pdf
- Gradual Roll-out of EUDAMED – Be ready to start: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf
- Spain application for in-house devices – For hospitals: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-una-nueva-aplicacion-para-la-comunicacion-de-fabricacion-de-productos-sanitarios-in-house-por-hospitales/
SMARTEYE
- Eqms Smarteye: https://eqms-smarteye.com/
EVENTS
- Arab Health – January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/
TRAINING
- Mini-Course MDR: https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/
ROW
- US – Some healthcare software are not devices – WARNING: https://www.fda.gov/media/184083/download?attachment
- Administrative support in healthcare settings.
- Promoting healthy lifestyles without direct links to disease management.
- Serving as electronic patient records without interpreting or analyzing data.
- Transferring, storing, converting, or displaying medical data without interpretation.
- Providing limited clinical decision support to healthcare providers without interpreting clinical tests or device data.
- US – PCCP Final guidance – Submit a PCCP with your submission: https://www.fda.gov/media/166704/download
• Webinar January 14, 2025 – https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin
- South Korea Guidance – Enhancing Medical Device Safety!: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=15564
- Australia – Guidelines for Medical Devices – Bookmark the link: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-medical-devices- argmd
- Australia – Submit Custom-made device – Guidance step-by-step: https://www.tga.gov.au/resources/resource/user-guide/how-submit-custom-made-medical-device-notification
- Malaysia – Advertisement application – Approve your Advertising: https://www.mda.gov.my/index.php/industry/medical-device-advertisements/medical-device-advertisement
PODCAST
- How MDR and IVDR code can save you money? Stefan Bolleininger: https://podcast.easymedicaldevice.com/309-2/
- Is FMEA bad for your Risk Management? Rod Beuzeval: https://podcast.easymedicaldevice.com/310-2/
- How to build the perfect Quality Management System? https://podcast.easymedicaldevice.com/311-2/
- IEC 60601-1-8 How to test your Medical Device Alarms? Beat Keller https://podcast.easymedicaldevice.com/312-2/
- PCCP – The magic tool for planned changes in the US? Maria Diez: https://podcast.easymedicaldevice.com/313-2/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News December 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. We will also review US vs EU regarding changes to SaMD.
Who is Maria Diez? María Diez is a seasoned expert in Quality Assurance (QA) and Regulatory Affairs (RA) for medical devices and in vitro diagnostic devices (IVDs), with over a decade of professional experience in the field. Holding a Ph.D. in Biochemistry and Molecular Biology, María has specialized in developing and maintaining Quality Management Systems (QMS) in compliance with standards such as ISO 13485, ISO 14971, and IEC 62304. She also brings extensive expertise in ensuring compliance with international medical device regulations, including those of the FDA, MDR, and IVDR. Additionally, María has significant experience in integrating advanced technologies, such as Artificial Intelligence (AI) and cybersecurity, into medical device software (MDSW) and Software as a Medical Device (SaMD).
Currently, María serves as a QA/RA Consultant at CMG MedDev, where she assists medical device manufacturers in bringing safe and effective products to market. Her expertise includes preparing technical documentation for CE marking, managing regulatory submissions for non-European markets, and helping companies navigate evolving global regulatory landscapes. María’s passion for education and innovation drives her active participation in industry conferences, where she shares her knowledge on AI-based MDSW/SaMD development and her experiences as a PRRC during the certification process.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Maria Diez LinkedIn: www.linkedin.com/in/maría-diez-zaera-46460323 * CMGMedDev website: https://www.linkedin.com/company/cmgmeddev/posts/ * PCCP guidance US: * https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial * https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post PCCP – The Magic tool for SaMD in the US? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Beat Keller from SMDC in Switzerland will help us to setup the right tests for your alarm systems. And you’ll see that it is not so obvious.
Who is Beat Keller?Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market quickly. Next to his experience in the medical device industry first as a software engineer, as project manager and later on as a regulatory affairs and quality manager, he is also member of different standardization working groups in Switzerland, on European level and internationally at IEC.
Who is Monir El Azzouzi?Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/ * SMDC website: https://www.smdc.ch * IEC 60601-1-8 Alarm System: https://webstore.iec.ch/en/publication/59648
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post IEC 60601-1-8 How to test your Medical Device alarms? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Blog: Does your Quality Manual look like that? https://easymedicaldevice.com/quality-manual/ * Video: How to get ISO 13485 certified? https://www.youtube.com/watch?v=paT2oR0uwjg * ISO 13485 standard: https://knowledge.bsigroup.com/products/medical-devices-quality-management-systems-requirements-for-regulatory-purposes?version=tracked * Blog: ISO 13485 Mandatory procedures: https://easymedicaldevice.com/iso-13485-procedure/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to build the perfect Quality Management System? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree.
Who is Rod Beuzeval? Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS systems, standards compliance, clinical evaluation, risk management, project management, and remediation activities. Rod has worked for a notified body, conducted audits against EN ISO 13485, and supported reviews of technical documentation for medical device manufacturers in Europe. His experience includes Class I, II, and III devices, software as a medical device, drug delivery devices, IVDs, and active implantable medical devices.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Leap Compliance LinkedIn: www.linkedin.com/company/leap-compliance * Leap Compliance website: www.leapcompliance.com * ISO 14971 Standard: https://www.evs.ee/en/evs-en-iso-14971-2019 * Video: What is ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U * Podcast: Why Risk Management is important for Medical Devices: https://podcast.easymedicaldevice.com/207-2/ * eQMS for Risk Management: https://eqms-smarteye.com/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Is FMEA bad for your Risk Management? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice.
Who is Stefan Bolleininger? Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/ * BeOnQuality Website: https://www.be-on-quality.com/ * MDCG 2019-14 – MDR code: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf * MDCG 2021-14 – IVDR code: https://health.ec.europa.eu/system/files/2021-07/md_mdcg_2021-14-guidance-ivdr-codes_en_0.pdf * EMDN Code: https://webgate.ec.europa.eu/dyna2/emdn/ * Notified Body database NANDO : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation * eQMS for Medical Devices: https://eqms-smarteye.com/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How MDR and IVDR code can save you money? appeared first on Medical Device made Easy Podcast. hamza benafqir
Medboardhttps://www.medboard.com/
EU Urgent update needed – EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf * HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf * EU Commission Newsletter – What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56793 * MDCG 2021-25 ;legacy devices & devices placed on the market prior to 26 May 2021: https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf * Blog post article: https://easymedicaldevice.com/legacy-devices-clarification-with-mdcg-2021-25/ * Notified Bodies Overview – How many still remaining: https://health.ec.europa.eu/do cument/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf * New MDR NEOEMKI in Bulgaria: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=0e4e49a1afef458542254b3556a5e83d85321b23&group=NOTIFICATION&download=true * HPRA Notification for In-house Manufacturers – Frequently Asked Questions: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/sur-g0053-faq-on-notification-for-in-house-manufacturers-of-medical-devices-and-in-vitro-diagnostic-medical-devices-v1.pdf?sfvrsn=8 * Harmonized Standards Summary List – For MDR and IVDR: * MDR: https://ec.europa.eu/docsroom/documents/62156/attachments/1/translations/en/renditions/native * IVDR: https://ec.europa.eu/docsroom/documents/62158/attachments/1/translations/en/renditions/native * MDCG 2024-11 – Qualification of IVDR: https://health.ec.europa.eu/document/download/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf * PMS is not implemented correctly – IGJ report is shocking: https://english.igj.nl/binaries/igj-en/documenten/publication/2024/10/08/call-to-medical-device-manufacturers-implement-an-effective-pms-system/20241003_Call+to+medical+device+manufacturers+implement+effective+PMS+system.pdf * Blog post: https://easymedicaldevice.com/how-can-i-do-my-post-market-surveillance/ * EUDAMED in Turkey – Message: You should use it: https://titck.gov.tr/duyuru/tcokka-tibbi-cihazlara-iliskin-avrupa-veri-tabani-hakkinda-teblig-taslagina-iliskin-duyuru-11102024094328 * Turkey registration limited – 10 per individual: https://titck.gov.tr/duyuru/tibbi-cihaz-belge-ve-urun-kaydi-yapan-firma-ve-kullanicilarina-iliskin-duyuru-07102024151251 * UK Post-Market Surveillance – New amendment:* https://www.legislation.gov.uk/ukdsi/2024/9780348264593/data.pdf
Training Team-NB training on Technical Documentation- November 6th:* https://www.team-nb.org/wp-content/uploads/2024/07/Leaflet-MDR-TD-Manufacturers-Training-20241106.pdf
EventsMedtechConf events – Check the MAP
- Afrisummit 2024 in Cairo November 3 to 6: https://medtechconf.com/event/afrisummit/
- MEDxD 2024 In Berlin November 7th: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/
- Medica 2024 in Dusseldorf November 11th: https://medtechconf.com/event/medica-2024/
ROWAustralia What is a Personalized Medical Device? – In Australia:* https://www.tga.gov.au/sites/default/files/2024-10/understanding-personalised-medical-devices%20rules-including-3d-printed%20devices.pdf * How to submit a notification on custom-made device in Australia: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
Mexico
GMP for Mexico – Draft document: https://www.dof.gob.mx/nota_detalle.php?codigo=5734591&fecha=26/07/2024#gsc.tab=0
South Africa South Africa and Australia MoU – Harmonization is on the way:* https://www.sahpra.org.za/news-and-updates/south-african-and-australian-health-product-regulators-to-share-regulatory-information-and-expertise/
PODCASTPodcast Nostalgia – Let’s review
- Episode 306 – What are the TOP 3 issues on CAPA with Georg Digel: https://podcast.easymedicaldevice.com/306-2/
- Episode 307 – What does a strategy for Regulatory Compliance Look like? https://podcast.easymedicaldevice.com/307-2/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News November 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So, let’s review that together.
Who is Adam Isaacs Rar? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video * ■ Adam Isaacs Rae linkedin Profile: https://www.linkedin.com/in/adam-isaacs-rae/ * ■ Webpage The Other Consultants: theotherconsultants.com
Social Media to follow * ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * ■ Twitter: https://twitter.com/elazzouzim * ■ Pinterest: https://www.pinterest.com/easymedicaldevice * ■ Instagram: https://www.instagram.com/easymedicaldevice
The post What does a strategy for regulatory compliance looks like? appeared first on Medical Device made Easy Podcast. hamza benafqir
in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team.
Who is Georg Digel? I’ve reviewed too many Medical Device CAPAs over the last 10 years. I think I’ve seen almost every mistake there is …Some of my “favorites”:
– Initiating CAPA without gathering facts
– Setting up KPIs but not monitoring them
– Confusing Correction with Corrective Action
To be honest – I’ve made many of these mistakes myself.
Luckily, I learned and improved. Over time, I even took on bigger responsibilities. Some projects which I really enjoyed:
– Process harmonizations for 60 sites
– Setup of training programs for 1.000+ people
– KPI dashboard implementations for 813 CAPAs
My learnings were paired with painful experiences. I want to save you from all of them. My goal is to help you:
- Avoid CAPA related audit findings or 483s
- Implement meaningful metrics for your CAPAs
- Train your people so they close records effectively
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Georg Digel LinkedIn: https://www.linkedin.com/in/georgdigel/ * Vincent Cafiso Podcast episode: Are you More Corrections or Corrective Actions or Preventive actions? https://www.youtube.com/watch?v=YsXfBv_AdWc * How to be the best at CAPAs with Karandeep Badwal: https://www.youtube.com/watch?v=zWK1U7d2awY * Most important issues on CAPAs: https://www.youtube.com/watch?v=lR4r14V5oHA
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What are the TOP 3 issues on CAPAs? appeared first on Medical Device made Easy Podcast. hamza benafqir
Medboard: https://www.medboard.com/
EUROPE* TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf * TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf * MDCG 2021-4 Rev 1 update- Deletion, revision, addition of questions: https://health.ec.europa.eu/document/download/9f23fca0-f407-4e45-a464-2d71b575d1fe_en?filename=mdcg_2021-4_en.pdf * Swissmedic – Deadline for Swissdamed – November 13th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/swissdamed/swissdamed-frist-13-11-24.html * Swiss review of old legislation devices – Check that all are up-to-date: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/aufforderung-ueberpruefung-altrechtlicher-produkte.html * UK on their new Regulation – Restart ongoing: https://medregs.blog.gov.uk/2024/09/25/an-update-on-our-plans-for-med-tech-regulatory-change/
EVENTS* TEAM-PRRC – October 17-18. 2024: https://medtechconf.com/event/team-prrc-third-annual-summit/ * Afrisummit – November 3-6, 2024: https://medtechconf.com/event/afrisummit/ * MEDICA – November 11-14, 2024 : https://medtechconf.com/event/medica-2024/
NB* ISS IVDR Notified Body – ISTITUTO SUPERIORE DI SANITA’: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1010586?organizationVersion=3
ROWMiddle East* Saudi Arabia: Labelling Guidance – What should contain a Medical Device Label in Saudi Arabia: https://www.sfda.gov.sa/sites/default/files/2024-10/MDS-014En.pdf
Northern America* USA webinar on Registation & Listing Requirements – In-Vitro Diagnostics and Laboratory Developed Tests: https://www.fda.gov/medical-devices/cdrhnew-news-and-updates/webinar-registration-listing-requirements-in-vitro-diagnostic-products-ivds-including-laboratory * USA Guidance on Dental products – Air Powered handpiece, Dental Cements, Dental Ceramics, Impressions: + Air powered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/air-powered-dental-handpieces-and-air-motors-performance-criteria-safety-and-performance-based + Dental Cements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-cements-performance-criteria-safety-and-performance-based-pathway + Dental Ceramics: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-ceramics-performance-criteria-safety-and-performance-based-pathway + Dental Impressions: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-impression-materials-performance-criteria-safety-and-performance-based-pathway * Canada policy on Drug/device combinations – Who is who?: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-drug-medical-device-combination-products-decisions.html
South America:* Brazil bans – Thermometers and Sphygmomanometers with a Mercury column: https://antigo.anvisa.gov.br/documents/10181/6873945/RDC_922_2024_.pdf/1e09cbf1-53db-4609-bea7-34afb7ce633c
PODCAST* Podcast Nostalgia – Last podcast to listen to- + Episode 302 – How to do PMCF literature Search for Medical Devices with Cesare Magri 4BetterDevices: https://podcast.easymedicaldevice.com/302-2/ + Episode 303 – UK vs EU vs US – How to switch to another region easily? With Claire Dyson DQS : https://podcast.easymedicaldevice.com/303-2/ + Episode 304 – How to select the best plastic for your Medical Device? Lucas Pianegonda Gradical: https://podcast.easymedicaldevice.com/305-2/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this.
Who is Lucas Pianegonda?Lucas Pianegonda is an expert for medical grade plastics, material testing and material compliance. He has experience as a material expert in ISO 13485 certified companies of several years, he knows the requirements the MDR makes towards medical devices and can translate these into material requirements. He has lead multiple projects on an international level successfully for topics like material change-overs, IP, bio compatibility and second source material qualification.
He is a self driven, communicative and assertive person, he loves challenges and he strives always for self improvement.
Who is Monir El Azzouzi?Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Lucas Pianegonda LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/?locale=en_US * Gradical website: https://gradical.ch/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to select the best plastic for your Medical Device? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US.
Who is Claire Dyson? Claire Dyson is a seasoned professional in the Med Tech space having spent more than a decade in manufacturing and the last 5 years in certification bodies. She began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and became Head of UK Approved Body for DEKRA in 2022. She recently resigned and is spending some time creating accessible content to support manufacturers with the regulatory transitions being implemented across Europe. Claire has set up her own company, CAPD Consultancy Ltd, whilst building up a network to help identify the needs across the industry and provide the right type of help that manufacturers need.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video* Claire Dyson Linkedin page: https://www.linkedin.com/in/claire-dyson-85845b4b/ * DQS website: https://www.dqsglobal.com/gb-en/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice * Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
The post UK vs EU vs US – How to switch to another region easily? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right.
Who is Cesare Magri? Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diagnostic manufacturers by leveraging clinical and non-clinical data for certification and marketing purposes. He has contributed to more than 100 clinical and performance evaluation for devices of all risk classes.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video * Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri/ * 4BetterDevices website: https://4betterdevices.com/ * Evidence link: https://evidence.systems
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to do a PMCF Literature Search for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
EU* e-IFU for medical devices – Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=EN * MDR Transition period – Visual timeline: https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf * Implementing Act IVDR Common specifiaction – Consultation until Sept 16th: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14383-In-vitro-diagnostic-medical-devices-common-specifications_en * Cyber Security in Health and medicine – Results from Cyber incidents: https://op.europa.eu/o/opportal-service/download-handler?identifier=9d3355cf-591f-11ef-acbc-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar∂= * How much cost a Notified Body? – Links available: https://health.ec.europa.eu/document/download/ff5716d5-fe77-4f45-b883-fcf3da4acd15_en?filename=md_nbs_fees_en.pdf
Switzerland* Swiss Combined Studies – Information Sheet to read: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/bw600_00_017e_mb_combined_studies.pdf.download.pdf/BW600_00_017e_MB_Information_combined_studies_KlinV_KlinVMEP.pdf * 3D Printing for Medical Devices – Reminder from Swissmedic: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_017d_mb_3d-drucker_mep.pdf.download.pdf/MU600_00_017e_MB_3D_printers_medical_devices.pdf
Training* EU MDR training September 23rd – Register Now: https://school.easymedicaldevice.com/course/gb33/
Events:* RAPS Convergence – September 17th to 19th California: https://medtechconf.com/event/raps-convergence-2024/ * AI ACT SUMMIT – October 1st :Online : https://medtechconf.com/event/ai-act-summit/ * Team-PRRC – October 17th – Malaga: https://medtechconf.com/event/team-prrc-third-annual-summit/ * Afrisummit – November 3-6 – Egypt: https://www.pharmaregafrisummit.com/ * Meds’d – November 7th – Berlin: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/
ROW* Australia: + Webinar: Software transition deadline on 1 November 2024 Reclassification needed: https://www.tga.gov.au/resources/event/webinars/software-reclassification-reforms-webinar-q-and-software-transition-deadline-1-november-2024 * USA + Voluntary malfunction Summary Reporting (VSMR) – Support the system: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/voluntary-malfunction-summary-reporting-vmsr-program-manufacturers + FDA Webinar: Remanufacturing of Devices – Distinction between servicing and remanufacturing: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/webinar-final-guidance-remanufacturing-medical-devices-09102024?utm_source=FDALinkedin + FDA DeNovo – Electronic Submission template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests + PCCP Draft Guidance – Plan your changes so they don’t need a review again: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices * Brazil: + Brazil UDI project – The world will be UDI soon: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/saiba-mais-sobre-o-projeto-de-identificacao-unica-de-dispositivos-medicos + Brazil Vigilance Reporting – e-Notivisa Launch: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/cidadaos-poderao-notificar-eventos-adversos-de-dispositivos-medicos-pelo-e-notivisa * Singapore + Singapore Change Management Program – Consultation on SaMD Guidance: https://www.hsa.gov.sg/announcements/regulatory-updates/consultation-on-guidance-on-change-management-program-(cmp)-for-samd * Bahrain + Guidance for registration of Medical Devices – Screenshot included: https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Device%20Importation%20Guideline-%20Ver%2011.1.pdf
Medical Device Live Expert:* Medical Device Live Expert – July August: + MDLE #2 – US EXPERT: Medical Device Live Expert #2 – US is in the place + MDLE #3 – EU MDR and IVDR Future: MDLE #3 – The Future of the MDR in EU, What Is?
Podcast* Podcast Nostalgia – July and August + AI ACT – What are the challenges for Medical Devices? Fabien Roy https://podcast.easymedicaldevice.com/292-2/ + EU Battery Regulation – How to be ready? Erik Vollebregt: https://podcast.easymedicaldevice.com/293-2/ + How to register your Medical Device in the UAE? Ahmed Hendawy: https://podcast.easymedicaldevice.com/294-2/ + EU MDR majow update: Interruption or Discontinuation of Supply! Erik Vollebregt: https://podcast.easymedicaldevice.com/295-2/ + IVDR Class D – Lesson learned from Notified Bodies. Andreas Stange: https://podcast.easymedicaldevice.com/296-2/ + How to use Harmonised Standards for Devices? Beat Keller: https://podcast.easymedicaldevice.com/297-2/ + Manage the Transfer/Renewal/ Surveillance/Change of your CE Certificate. Ralf Gansel: https://podcast.easymedicaldevice.com/298-2/ + How to grow from Zero to Hero in Medical Device? Stephan O’Rourke: https://podcast.easymedicaldevice.com/299-2/ + Episode 300: How to use AI GPT for your QA RA work? Martin King: https://podcast.easymedicaldevice.com/300-2/
The post Medical Device News, Septembre 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls.
Who is Martin King? Martin Cranston King, a Swiss consultant working with medical devices, in vitro diagnostics (IVD), and pharmaceuticals since 1979. Martin is a leading expert in quality assurance, regulatory compliance, and product development, developing active wearable devices since the 1980s.
Known for his hands-on approach and deep understanding of complex regulatory environments, Martin has guided companies around the globe through successful regulatory submissions. His expertise spans across six continents, making him a sought-after advisor in his field.
Martin holds advanced degrees in Micro-electronics and Materials Science, and Electronic Engineering. He is a trained Lead Auditor for ISO 13485:2016 and is well-versed in international standards such as 21 CFR 820 and MDR 745/2017. Recognized as one of the top 25 MedTech Leading Voices on LinkedIn, Martin also shares valuable insights through his popular weekly regulatory roundup.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Martin Kings LinkedIn: https://www.linkedin.com/in/martink2/ * QARA Whatsapp group: https://chat.whatsapp.com/Dkl3XrjiXzW51Fgipf96k2 * QARA Whatsapp channel: https://whatsapp.com/channel/0029VaaBTj9CxoAwG0CUBn1x
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to use AI GPT for your Quality and Regulatory work? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field.
Who is Stephen O’Rourke? Stephen O’Rourke, based in Berlin, Germany, is a seasoned regulatory affairs expert with extensive experience across the food, biotech, and medical device industries. With deep expertise in EU and global regulations, he is dedicated to helping companies navigate complex regulatory landscapes, ensuring the successful launch of innovative products. His journey and transition into medical device regulation began at one of Europe’s largest clinics, where he was instrumental in kickstarting their MDR consultancy. Outside of his regulatory work, Stephen is an advocate for transparency and accountability in politics, having run for the European Parliament in 2024 to champion these causes. He is also actively involved in promoting Ireland’s traditional sports and enjoys exploring Berlin with his family.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Stephen O’Rourke LinkedIn: https://www.linkedin.com/in/sorourkede/ * AI Act Summit Link: https://medtechconf.com/event/ai-act-summit/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to go from Zero to Hero in Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance…
Who is Ralf Gansel?With over a decade of experience in the medical health sector and equipped with a subtly dry sense of humor, Ralf committed to bringing transformative medical technologies to the EU and global markets by leveraging his extensive expertise in regulatory frameworks and market dynamics.
At TÜV SÜD in the Medical & Health Services Business Unit , Ralf head the Special Operations and Support department. He is specialized in onboarding and supporting new clients, dealing in the field of active and non-active devices, implantables, and IVDs. His role focuses on advancing technological innovations and ensuring their market success while meeting EU and international regulatory requirements.
Who is Monir El Azzouzi?Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Ralf Gansel LinkedIn: https://www.linkedin.com/in/ralf-gansel/ * TÜV SÜD website: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
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Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion with Beat Keller on how to use them correctly.
Who is Beat Keller? Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market quickly. Next to his experience in the medical device industry first as a software engineer, as project manager and later on as a regulatory affairs and quality manager, he is also member of different standardization working groups in Switzerland, on European level and internationally at IEC.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/ * SMDC website: https://www.smdc.ch * EU IVDR harmonized standards: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en * Swiss harmonized standards: https://www.switec.info/de/neue-harmonisierte-normen/ * US FDA Recognized Consensus Standards: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/results.cfm
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to use Harmonized Standards for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100th class D certificates they issued. We will also review the timeline for IVDR and explain the next deadline which is in October. So be aware of it now.
Who is Andreas Stange?
Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link
Andreas Stange Linkedin Profile: https://www.linkedin.com/in/andreasstange/
TÜV SÜD Website: https://www.axonlawyers.com/
EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be integrated to the EU MDR where medical device manufacturers have to inform about interruption of supply. So what will be the requirements and what should you do. Listen to it to know more.
Who is Erik Vollebregt?
Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ * Axon Lawyers Website: https://www.axonlawyers.com/ * EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320 * Medical devices: Council adopts new measures to help prevent shortages https://data.consilium.europa.eu/doc/document/PE-54-2024-INIT/en/pdf * Article Judith de Wildth – How to prepare for article 10a: https://www.linkedin.com/posts/erikvollebregt_how-to-prepare-for-article-10a-mdr-as-a-manufacturer-activity-7216378083308646401-vqzF * EUDAMED roll-out timeline: https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post EU MDR Major update: Interruption or Discontinuation of supply! appeared first on Medical Device made Easy Podcast. hamza benafqir
Registration of Medical Devices can be complicated. But here we will share with you the process for the United Arab Emirate where the famous city of Dubai is located. Ahmed Hendawy from Registitute is helping us to understand this process and he confirms that it is really simple. So no way that you miss this.
Who is Ahmed Hendawy? Ahmed is an esteemed leader in the field of healthcare consulting, renowned for his deep expertise in healthcare regulations, market access, and business strategy within the MENA region. As the founder and driving force behind Registitute, Ahmed has established the firm as a premier provider of specialized services in regulatory affairs and market access. With a distinguished career, including a previous role as the Head of Regulatory Affairs for the MENA region, Ahmed has demonstrated exceptional skill in navigating complex regulations and spearheading successful market entry strategies. Under his visionary guidance, Registitute has garnered a reputation for excellence and innovation in the healthcare consulting landscape. Registitute stands apart by delivering tailored solutions that address the unique challenges faced by healthcare organizations operating in the MENA region. Ahmed’s strategic vision, combined with the expertise of the Registitute team, continues to drive positive change and support healthcare organizations in adapting to the ever-evolving healthcare landscape in the MENA region. In summary, Ahmed’s leadership and Registitute’s unwavering commitment to providing exceptional services position them as a trusted partner for healthcare organizations seeking regulatory expertise and market access support in the MENA region.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Links from the Video * Ahmed Hendawy Linkedin : https://www.linkedin.com/in/ahmed-hendawy-a0a81511a * Registitute LinkedIn: https://www.linkedin.com/company/registitute/ * Registitute Website : www.registitute.com * AL TIRYAQ LinkedIn : https://www.linkedin.com/company/al-tiryaq/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to register your Medical Device in the UAE? appeared first on Medical Device made Easy Podcast. hamza benafqir
More and more regulations have to be applied in parallel of the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon Lawyers will be explaining to us what are these additional requirements. He will also confirm that Notified Bodies can ask you questions about it and finally he will share some key timelines for its implementation. Spoiler Alert ! first is August 2024 so be quick.
Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Links from the Video * Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ * Axon Lawyers Website: https://www.axonlawyers.com/ * EU Battery Regulation: https://data.consilium.europa.eu/doc/document/ST-10488-2023-INIT/en/pdf
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post EU Battery Regulation – How to be ready? appeared first on Medical Device made Easy Podcast. hamza benafqir
You are working with a Software that contains an AI/ML algorithm then you should listen to this podcast episode and understand the requirements of the AI ACT to your medical device. Fabien Roy, lawyer will explain to us what are the challenges that he has identified for medical device manufacturers working with Artificial Intelligence.
Who is Fabien Roy? I am an EU pharma/device lawyer and problem solver. My practice focuses on European Union (EU) and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. I am following very closely the new regulations on medical devices (MDR and IVDR), the GDPR and regularly advise clients in relation to the requirements applicable to their digital health technologies. I focus particularly on the different stages of the medical device CE marking process and advise on a wide variety of topics which include the following:
- – determination of the appropriate classification of individual products;
- – clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data);
- – drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements;
- -clinical data requirements and clinical evaluation;
- – conformity assessment procedure;
- – review of Instruction For Use, products’ labelling and promotional material including websites;
- – post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal;
- – preparation and review of technical documentation;
- – reimbursement. I also advise on questions regarding marketing authorisation procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector. Specialties: Regulation of medical devices and medicinal products in the EU
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Fabien Roy Linkedin Profile: https://www.linkedin.com/in/fabien-roy-83b55021/ * Company Website: * Ai Act text:
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post AI Act – What are the challenges for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
MedboardEU* Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422 + Title: MDR and IVDR next steps – Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/ * MDCG 2022-13 Rev1 – Extension of the scope of designations: https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf * MDCG 2024-10 Clinical Evaluation of orphan medical devices : For RARE DISEASES: https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf * Scheer – Brain Stimuilators -: Risks associated with Brain Stimulators: https://health.ec.europa.eu/consultations/scheer-call-external-experts-scheer-wg-risks-health-associated-use-brain-stimulators-not-having_en * Fast access to Clinical Trial Information -: New CTIS: https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europe * AI Supervision required – AI ACT: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly
UK* UK USA and Canada on AI – Guiding Principles: https://assets.publishing.service.gov.uk/media/66670b9be8d5f2d4bdfcbb37/transparency_ml-enabled_devices_guiding_principles.pdf
Swiss* SWISSDAMED Actors Module – Open in August 6th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/release-notes.html
MEDTECH CONF* Medicall August 2nd 2024 – Chennai, India: https://medtechconf.com/event/medicall-chennai-2024/ * RAPS Convergence Sept 17-19 2024 – Long Beach, California, USA: https://medtechconf.com/event/raps-convergence-2024/ * AI Act Summit October 1st 2024 – Strasbourg, France: https://medtechconf.com/event/ai-act-summit/
LIVE SESSION* Medical Device Live Expert #1 – Replay: https://www.youtube.com/watch?v=RrzXj36Yrqc * Medical Device Live Expert #2 – US is in the place: https://www.linkedin.com/events/medicaldeviceliveexpert-2-usais7214180765008359424/theater/
US* Essential Drug Delivery Outputs for Devices Guidance – Learn FDA requirements for EDDOs: https://www.fda.gov/media/179545/download * Recognized Standards – Change happens: https://www.govinfo.gov/content/pkg/FR-2024-06-24/pdf/2024-13777.pdf * US Webinar IVD classification -: July 16th 1pm EST: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-in-vitro-diagnostic-product-ivd-classification-07162024 * Blog post – The promise of AI in Health Care – FDA knows: https://www.fda.gov/medical-devices/digital-health-center-excellence/blog-promise-artificial-intelligence-holds-improving-health-care
Australia* Australia: Exempt Medical Device – They should still follow the rules: https://www.tga.gov.au/resources/resource/guidance/regulatory-obligation-exempt-medical-devices * Cosmetics or therapeutics -TGA helps you to decide: https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf * : Essential Principle Checklist -Template available: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist * AusUDID is in the place – Australian UDI Database for sponsors and manufacturers: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/australian-udi-database-sponsors-and-manufacturers
Saudi Arabia* Extend Shelf Life – in case of Public emergency: https://tinyurl.com/EMDpod
Malaysia* Workshop Post-Market Requirements – July 16th, 2024: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly * Training: How to submit documents – July 17th, 2024: https://portal.mda.gov.my/index.php/doclink/program-8-hands-on-medcrest-post-market-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJwcm9ncmFtLTgtaGFuZHMtb24tbWVkY3Jlc3QtcG9zdC1tYXJrZXQtcGRmIiwiaWF0IjoxNzE4MjQ5OTgzLCJleHAiOjE3MTgzMzYzODN9._ZObFPlzSpQWnAoPKDxH_J8IWhmcTDNLsFpYe0AkO9M * Are you satisfied with Malaysia MDA – You can rate here: https://www.mda.gov.my/index.php/news/1418-kajian-kepuasan-pelanggan-mda-1-2024
South Africa* SAHPRA Medical Device Vigilance- Who to contact: https://www.sahpra.org.za/wp-content/uploads/2024/06/Contacts-for-Adverse-Events-Recalls-and-Market-Actions.pdf
PODCAST* Episode 288 – Cleaning Validation – How to select the worst case (Heena Thakkar): https://podcast.easymedicaldevice.com/288-2/ * Episode 289 – AFNOR- How is a Notified Body designated: (Thomas Lommatzsch): https://podcast.easymedicaldevice.com/289-2/ * Episode 290 – How to submit your AI/ML SAMD the right way? (Richie Christian): https://podcast.easymedicaldevice.com/290-2/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
You don’t know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important elements that you should take care off before to submit your dossier to your Notified Body or your Competent Authority. So enjoy.
Who is Richie Christian?Richie Christian has more than 10 years of experience in medical device regulatory and quality. He has a Master’s degree in neurophysiology from the University of Auckland, and is passionate about digital transformation of the healthcare industry. Throughout his career, Richie has worked in numerous regulatory and quality roles with not only traditional hardware device manufacturers, but also cutting-edge AI/ML-enabled SaMD manufacturer.
In his most recent role as the Head of Regulatory and Quality, he spearheaded the development and implementation of a streamlined QMS, enabling them to achieve MDSAP certification and secure market authorisations for an innovative orthopaedics AI/ML-enabled SaMD in USA and Japan.
Richie relocated to Basel, Switzerland from New Zealand as a consultant for wega Informatik where he now applies his decade-long experience to help companies develop and deliver compliant medical device software.
Who is Monir El Azzouzi?Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Links* Richie Christian Linkedin Profile: https://www.linkedin.com/in/christianrichie/ * Wega Website: https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance * AAMI/BS standard https://knowledge.bsigroup.com/products/application-of-iso-14971-to-machine-learning-in-artificial-intelligence-guide?version=standard * Good Machine Learning Practice for Medical Device Development: Guiding Principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles * Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to submit your AI/ML SAMD the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir
If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authorities… So stay tuned.
Who is Thomas Lommatzsch? Thomas LOMMATZSCH heads the Medical Business Unit of AFNOR Certification, which deals with the certification of medical devices within the notified body AFNOR Certification (NB0333). With over 20 years’ experience within Notified Bodies under various European regulations, he has completed several notification projects, most recently the AFNOR Certification notification project under the MDR. Thomas is also involved in standardization work relating to the application of the AI Act, particularly with its application to medical devices.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Thomas Lommatzsch Linkedin Profile: https://www.linkedin.com/in/thomas-lommatzsch/ * AFNOR webpage: https://certification.afnor.org/qualite/marquage-ce-dispositifs-medicaux * EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320 * EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320 * French competent authority ANSM: https://ansm.sante.fr/ * JAT Joint Assessment: https://health.ec.europa.eu/document/download/b9d671f5-02d0-44b1-a207-b07aeb4ef931_en?filename=md_info_ja_mdr_en.pdf * MDCG 2022-13 Designation, re-assessment and notification of conformity assessment
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post AFNOR – How is a Notified Body designated? appeared first on Medical Device made Easy Podcast. hamza benafqir
Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers.
Who is Heena Thakkar? Heena Thakkar is a regulatory consultant currently working with Alceon Medtech Consulting. She is based in Gujarat, India. Heena is qualified in risk management, design controls, usability engineering, clinical evaluation, clinical trial management, quality management systems and process validation. She is also a certified internal auditor.
Heena has around 8 years of experience in the field of regulatory affairs and quality management system for medical devices. She is experienced in regulatory submissions for vast range of devices ranging from orthopaedic devices, endovascular devices, single-use consumables, ophthalmic devices and wound care devices. She also conducts external trainings in the areas such as risk management, quality management system, EU MDR and EU IVDR.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Heena Thakkar Linkedin Profile:
https://www.linkedin.com/in/heenathakkar?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app
- Alceon Medtech Consulting Website:
Home
- List of standards helpful for cleaning validation of reusable instruments
- ANSI/ AAMI ST98: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices https://www.aami.org/standards/featured-standards/aami-st98
- USFDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (https://www.fda.gov/media/80265/download)
- ISO 17664-1:2021: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (https://www.iso.org/standard/81720.html)
- ISO 15883-1:2006: Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (https://www.iso.org/standard/41076.html)
- ISO 15883-5:2021: Washer-disinfectors – Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (https://www.iso.org/standard/68297.html)
- ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3208-20.html)
- ASTM F3293-18: Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3293-18.html)
There are many additional standards that manufacturers will need to refer to in addition to the ones listed above. Contact us at contact@alceonconsulting.com for additional information or service inquiry. Thank you!
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Cleaning Validation – How to select the worst case? appeared first on Medical Device made Easy Podcast. hamza benafqir
- EUROPE
- EU MDR 26 May 2024 – Was there any apocalypse:
- France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition
- Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering
- EU shortage managed – EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320
- EMA Q&A on Combination products – Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
- EU talks about SoHo -: Substances of Human Origin
- https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_8_2024_INIT&qid=1716536451356
- https://www.consilium.europa.eu/en/press/press-releases/2024/05/27/council-adopts-new-rules-on-substances-of-human-origin/
- Italy Database error – Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569
- Ireland guide on In-House IVDs – Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8
- Combined Studies in the EU – COMBINE PROJECT:
- https://ec.europa.eu/newsroom/sante/items/830485/en
- https://health.ec.europa.eu/document/download/77e1409a-f4c0-45db-bff1-4873c7a0e7ae_en?filename=md_combined-analysis-phase-report.pdf
- EU MDR 26 May 2024 – Was there any apocalypse:
- Notified Bodies
- Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
- Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf
- New Notified Bodies for EU MDR –
- MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1
- Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18
- QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1
- UK
- UK on international recognition – Approve products without CE or UKCA mark:
- https://www.gov.uk/government/news/mhra-announces-a-proposed-framework-for-international-recognition-of-medical-devices
- https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices
- UK implementation of Future Regulation – When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
- UK Common Specifications for IVD – Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices
- UK suspected counterfeit Medical Device – How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device
- UK Ai Airlock – Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence
- Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-airlock-the-regulatory-sandbox-for-aiamd-in-healthcare-webinar-tickets-896407919217
- UK on international recognition – Approve products without CE or UKCA mark:
- Easy Medical Device: eQMS SmartEye
- Video: One of the best eQMS for Medical DevicesOne of the best eQMS for Medical Devices
- Events:
- Medtech Conf:
- Title: International Medical Device Exhibition and Conference – Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/
- Medtech Conf:
- Training
- Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/
- EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
- WORLD
- US
- US Remanufacturing or Servicing – Webinar replay included:
- https://www.fda.gov/media/150141/download
- Webinar: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-guidance-remanufacturing-medical-devices-06272024
- US – Use of Patient Generated Data – Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case
- US Laboratory Developed Tests – Final rules defined and Webinar to explain:
- https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024
- https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-frequently-asked-questions
- https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests
- US Remanufacturing or Servicing – Webinar replay included:
- Australia
- Australia – in-house IVDs requirements – Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds
- Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf
- Saudi Arabia
- Saudi Arabia – Webinar Biological Evaluation – 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404
- Nigeria
- Guidance to register Medical Devices – Registration, labelling and advertising:
- https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Registration-Regulations-2024.pdf
- https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Labelling-Regulations-2024.pdf
- https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Advertisement-Regulations-2024.pdf
- Guidance to register Medical Devices – Registration, labelling and advertising:
- India
- CDSCO laboratory testing – But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg=
- Malaysia
- Malaysia Guidance for Medical Device – Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device
- Hong-Kong
- Overview of a Local Responsible Person – Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
- Singapore
- Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md
- US
- PODCAST
- Podcast Nostalgia – What topics were discussed
- Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/
- Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/
- Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/
- Episode 286: Summative Evaluation – Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/
- Podcast Nostalgia – What topics were discussed
The post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is IEC 62366. On this episode, Amandine Broussier will specifically focus on one part of usability which is the Summative Evaluation. She will explain what this is and when it should be done. So listen to this to be an expert in Usability.
Who is Amandine Broussier Amandine Broussier is an independent medical devices usability specialist who supports medical device manufacturers in their usability engineering process (EN 62366-1:2015). She has 8 years of experience in the usability engineering, working with around 30 manufacturers on different devices (hardware, software) (class II, class III and IVD).
Amandine can help you through all stages of the usability engineering process including auditing your current usability documentation with recommendations for improvement, identifying of use-related risks, writing the different documents required by the EN 62366-1 standard, and carrying out your formative and summative evaluations for CE marking and FDA approval. She also provides introductions to usability engineering for companies to help them understand the expectation of notified bodies with regards to usability standards.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link * Amandine Broussier Linkedin Profile: https://www.linkedin.com/in/amandine-broussier-888a41113/ * IEC 62366-1 link: https://www.iso.org/fr/standard/63179.html * IEC 62366-1/A1 link: https://www.iso.org/fr/standard/73007.html * IEC 62366-2: https://www.iso.org/fr/standard/69126.html
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Summative Evaluation – Common mistakes appeared first on Medical Device made Easy Podcast. hamza benafqir
Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today we will explain to you with Vincent Cafiso what are Correction, Corrective Actions and Preventive Actions.
Who is Vincent Cafiso Named as one of MD+DI’s 24 Medtech Voices to Follow in 2024, Vincent Cafiso is a former U.S. FDA Investigator with 30-years of medical device and in vitro diagnostics (IVD) industry experience and is currently the Founder and Managing Consultant for his firm Practical Compliance Results. Vincent prepares his clients to be ready for their next FDA inspection and Notified Body audit consulting in the areas of compliance, quality assurance, and quality systems.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Vincent Cafiso Linkedin Profile: https://www.linkedin.com/in/vincentcafiso/ * CREO Consulting Website: https://creoconsulting.com/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Are you more Corrections or Corrective Actions or Preventive Actions? appeared first on Medical Device made Easy Podcast. hamza benafqir
Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are only your supplier and not the legal manufacturer of the product. So now the question is how to select them and also how to handle them. Let’s find that out with Keith Smith from Vonco
Who is Keith Smith?
Keith Smith is the President and CEO of Vonco Products. Keith has a passion for cultivating infectious energy, innovation, and creation. He generously contributes time and resources to entrepreneurial, education, athletic, and health endeavors. Prior to acquiring Vonco in December of 2012, he served as a General Manager of Carbonless Rolls and Security Papers for Appleton Papers, the largest division of a $1BN paper company. Keith holds a bachelor’s degree in industrial engineering as well as an MBA from Northern Illinois University and Lean and Six Sigma certifications from the University of Michigan.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link
Keith Smith Linkedin Profile: https://www.linkedin.com/in/keith-smith-725508b/
Keith Smith Website: https://keithsmith.io/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Michael Israel from Zuper.co is helping us understand the world of Field Service and then we can understand better how some information collected by Field Service Engineer can help Quality Department to have a better operation. Collect machine performance, train technicians, identify issues.
Michael will also talk about Zuper which is a FSM software (Field Service Management) and can help you save time and collect the write information. So don’t hesitate to check his website.
Who is Michael Israel?
Michael Israel is Vice President of Community and a member of the executive leadership team at Zuper. Michael has worked in customer and field service for more than 40 years. He spent 20 years in his early career managing both domestic and international field service operations, including 12 years with IBM’s Field Engineering organization. Over the past three decades, he has held management and executive roles with major providers of CRM and Field Service software applications, including tenures with IFS, Oracle, and SAP.
His broad experience includes marketing, selling, supporting, and implementing CRM and Field Service software applications. Michael also served as a Field Service analyst for Aberdeen Group, the Technology Services Industry Association (TSIA), Jolt Consulting, and the Service Council.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link
Michael Israel Linkedin Profile: https://www.linkedin.com/in/michaelisrael1/
Zuper Website: https://zuper.co
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
EU
Notified Bodies
TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true
AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1
MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf
Form: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F54cbbfd4-5808-4560-93ef-017f2a3b0f41_en%3Ffilename%3Dmdcg_2024-4_appendix_en.xlsm&wdOrigin=BROWSELINK
MDCG 2024-5 Guidance – SInvestigator's Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf
Checklist 2024-5 https://health.ec.europa.eu/document/download/a387e3e7-65e3-4af5-bb98-2281949feded_en?filename=mdcg_2024-5-appendix-a_en.docx
Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar∂=
Team-NB: ESMINT initiative – Call for expert: https://www.team-nb.org/esmint-initiative/
Spain AEMPS Bulletin on Health Products – From Jan - March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan
Germany: Classification - Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html
Swiss: SaMD – information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf
Turkey: 26 May 2024 – Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706
Article to read
European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf
Training
Training EU MDR – Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/
Malaysia training – Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI
Team-NB training - IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/
Events
Events – Check Medtech Conf: https://MedtechConf.com
Rest of the world
South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do
South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)
South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1
Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0
Australia: Consultation on IFU – Call for more flexibility: https://www.tga.gov.au/resources/consultation/consultation-availability-instructions-use-ifu-more-flexible-formats
Podcast
Radiation Sterilisation Master File - Adam Issacs Rae: https://podcast.easymedicaldevice.com/279-2/
What is the impact of AI Act on Medical Devices – Erik Vollebregt: https://podcast.easymedicaldevice.com/280-2/
Why and how to build your Quality Culture – Lesley Worthington: https://podcast.easymedicaldevice.com/281-2/
A quality culture seem to be a nice to have. But after listening this podcast episode with Lesley Worthington, you will see that it is worth to build one. We will review the description of a quality culture and how to build it. But also if this is required by a regulation and how you can align it with your compliance duties. Check this and share it with your team.
Who is Lesley Worthington? Lesley works with individuals and teams to fine-tune their Quality conversations, initiatives, and internal communications to create a better understanding of the role and concepts of quality assurance throughout their organization.
Through her leadership and executive coaching, she supports professionals as they work on improving their relationships and effectiveness in their roles allowing them to achieve their fullest potential, professionally, and empowering them to move their organizations toward a robust Quality Culture.
She runs a community, The Quality Network, which supports Quality professionals as they work on the skills that allow them to build a Quality Culture. The Quality Network is a place for learning, coaching, support, and networking and includes webinars, resources, a member platform, courses, and office hours.
She combines 20 years of quality and regulatory experience in medical devices, in Canada, with thousands of hours of teaching and coaching to provide her clients with the skills, techniques, insights, and mindset that raise their confidence, take their communication skills to the next level, and allow them to have a positive impact in their organizations.
She’s got a Psychology Degree, a Law Degree, English as a Second Language Teaching Qualifications, and is a Certified Executive Coach.
Who is Monir El Azzouzi? Monir El Azzouzi, a distinguished expert in the medical device sector, holds a Biomedical Engineering degree from ISIFC in France. With extensive experience at top-tier companies such as Bausch+Lomb, Aesculap, and Johnson & Johnson, Monir has a deep understanding of the industry’s challenges and opportunities. His commitment to enhancing industry standards and support led him to establish Easy Medical Device.
Easy Medical Device is an innovative company dedicated to enriching the medical device community through educational outreach such as podcasting, blogging, and video creation. The company also offers specialized training programs, notably the Green Belt Certificate for EU MDR, to elevate professional skills within the industry.
Beyond education, Easy Medical Device provides comprehensive consulting services, helping manufacturers navigate the complexities of CE Marking, FDA registration, clinical evaluation reports, internal audits, design and development, supplier reviews, eQMS implementation, and due diligence. Our expertise extends to acting as authorized representatives and importers in Europe, Switzerland, and the UK, facilitating smoother market entry for our clients.
Monir’s vision for Easy Medical Device is to establish it as the definitive one-stop shop for all services related to medical device manufacturers. We are committed to assisting you in introducing and advancing your projects with efficiency and compliance.
Do not hesitate to contact Monir El Azzouzi at Easy Medical Device to explore how we can support your medical device initiatives.
Links* LinkedIn: https://www.linkedin.com/in/lesleyworthington/ * Website: https://lesleyworthington.com/ * Email: lesley@lesleyworthington.com
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Why and how to build a Quality Culture? appeared first on Medical Device made Easy Podcast. hamza benafqir
The AI Act or Artificial Intelligence Act is now a reality. But what does it mean for the Medical Device industry and what should you do within your Quality or Regulatory affairs activities.
Erik Vollebregt, from Axon Lawyers will tell us what we should understand with this new legislation and what are the consequences for the Medical Device community.
Who is Erik Vollebregt?
Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ * Axon Lawyers Website: https://www.axonlawyers.com/ * Erik Blog: https://medicaldeviceslegal.com/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What is the impact of AI Act on Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the life to the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant.
Who is Adam Isaacs Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:
- Adam Isaacs Rae linkedin Profile: https://www.linkedin.com/in/adam-isaacs-rae/
- ISO 11137- Radiation standards : https://www.iso.org/standard/33952.html
- ISO 11607 – Packaging of terminally sterilised products: https://www.iso.org/standard/70799.html
- ISO 11737 – Bioburden: https://www.iso.org/standard/66451.html
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Radiation Sterilisation Master File (ISO 11137 & 11607) appeared first on Medical Device made Easy Podcast. hamza benafqir
Sponsor: Medboard: https://www.medboard.com/
EU* MDR and IVDR national languages update – France accepts English + MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf + IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_sector_lang-req-table-ivdr.pdf * Which devices for Expert Panel – Active Implantable Device on Top: https://health.ec.europa.eu/document/download/4c43abea-b989-434b-9ac1-94134bf1a538_en?filename=md_annual-overview-cecp-2022-2023_en.pdf + 94.4% for Class III implantable and 5.6% for Class Iib Administer or remove medicinal products + On Class III implantable – Top is with Active Implantable Devices + Exempt devices are mainly within 3 categories (Main reason: Modification of a device already marketed): - Vascular and cardiac prostheses - Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligaments synthesis - Implantable prosthetic and osteosynthesis devices * Annex XVI: Is Brain Stimulation device risk? – SCHEER should evaluate by End 2025: https://health.ec.europa.eu/document/download/e6de1e88-2821-48f6-98f9-a56ea61cbfad_en?filename=scheer_q_031.pdf + SCHEER = Scientific Committee on Health, Environmental and Emerging Risks * SCHEER on Phtalate – Update of the guidelines: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-update-scheer-guidelines-benefit-risk-assessment-presence_en + Consultation until April 28th, 2024 * MDCG subgroup Agenda – What is coming?: https://health.ec.europa.eu/document/download/f588a5c8-57af-48aa-808f-1d9c02f4925a_en?filename=mdcg_ongoing-guidance_0.pdf * MDCG 2024-3 on CIP – Clinical Investigation: https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en.pdf * New Notified Body RISE Sweden – Welcome to the team 3033: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=d37c034bc695d2e143b5145b4cb7cd73caf8983c&group=NOTIFICATION&download=true + 44 MDR NB + 12 IVDR NB
UK* MHRA: Electrical Devices in Clinical Trials – Advice on application with separate document: https://assets.publishing.service.gov.uk/media/65fb0d66aa9b76001dfbdc28/MHRA_Electrical_Guidance_for_Clinical_Investigations_Modified_12_Feb.pdf
Ireland* HPRA Newsletter- IVD, Eudamed, Custom-made, Clinical trials: https://www.hpra.ie/docs/default-source/publications-forms/newsletters/hpra-medical-devices-newsletter-issue-57-february-2024.pdf
Turkey* Reminder on MDR transition period – May 26th, 2024: https://titck.gov.tr/storage/Archive/2024/announcement/duyurumetni_67231ed0-2553-4708-8231-7951c767e066.pdf + Turkey strongly inform the different parties regarding MDR transition
Events* RAPS Euro Convergence – May 6-8 in Berlin-Germany: https://www.raps.org/europe-2024/home * Medtech Conf Map: https://medtechconf.com/event/connect-with-european-andinternational-regulatoryaffairs-peers-in-berlin-2/
Services* Packaging for Medical and Pharmaceutical – Design, Manufacturing and delivery: https://easymedicaldevice.com/packaging-for-medical-devices/
ROWUSA* Ban devices – Electrical Stimulation Devices for Self-injurious or Aggressive Behavior: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans + CNN article: https://edition.cnn.com/2024/03/25/health/fda-ban-electrical-stimulation-devices/index.html + Comments open until May 28, 2024: https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-proposes-new-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior + Bans - Prosthetic Hair Fibers since 1983 - Powdered Surgeon’s Gloves since 2017 - Electrical Stimulation Devices for Self-injurious or Aggressive Behavior since March 2024 * Animal Studie for Dental Bone Grafting devices – Choose the right animal Model: https://www.fda.gov/media/177340/download + Minimum of 3 animals + Animal Model: Canine and Porcine model instead of rodents * FDA: Deviations on Neuralink lab – Animal Study good practices: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-finds-problems-animal-lab-run-by-musks-brain-implant-company-2024-02-29/ + Calibration of equipment’s are not done + Quality officials not signing documents
Australia* Vigilance Reporting in Australia – For Recall and non-Recall: https://www.tga.gov.au/sites/default/files/2024-03/uniform-recall-procedure-therapeutic-goods-urptg.pdf + Recall action Template: https://www.tga.gov.au/resources/resource/forms/recall-action-templates
Saudi Arabia* Guidance on Surgical Sutures – This contains some cheat code: https://www.sfda.gov.sa/sites/default/files/2024-03/%28MDS-G021%29En.pdf + Endpoints that should be addressed + Laboratories should be ISO/IEC 17025 + Shelf life should follow ASTM F1980
Brazil* MOU between Brazil and Paraguay – Memorandum of Understanding: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-e-agencia-reguladora-do-paraguai-assinam-primeiro-memorando-de-entendimento + Bilateral cooperation on health surveillance + Strenghtening regulatory capacity * GMP validity from two to four years – If certified through MDSAP: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-amplia-para-quatro-anos-prazo-de-validade-do-certificado-de-boas-praticas-de-fabricacao * Prioritize registration of Dengue Diagnosis Devices – Submit Now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-prioriza-registro-de-dispositivos-para-diagnostico-da-dengue + Combat dengue epidemic as a matter of urgency
India* CDSCO: PSUR through online portal – From April 1st, 2024: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwMTI= + Online portal: https://www.cdscomdonline.gov.in/NewMedDev/Homepage
Malaysia* Malaysia Faster approval – Establishment license application: https://www.mda.gov.my/index.php/announcement/1377-faster-approval-for-establishment-license-application-complete-applications-processed-within-14-21-working-days + 14 to 21 Working days from date of application + List of documents within the link
China* China Guidelines on registration – Specific products: https://www.cmde.org.cn/xwdt/zxyw/20240318133300123.html + Corneal Topograph + Laparoscopic surgery system + Optical Radiation Safety device + Monkeypox virus nucleid acid detections agent: https://www.cmde.org.cn/xwdt/zxyw/20240318111545184.html
Podcast* Podcast Nostalgia + Episode 275 – FDA aligns QMSR with ISO 13485 (Naveen Agarwal): https://podcast.easymedicaldevice.com/275-2/ + Episode 276 – How to do Postmarketing Surveillance to right way? (Steve Curran): https://podcast.easymedicaldevice.com/276-2/ + Episode 277 – How to benefit from Survey to build Clinical Evidence? (Cesare Magri): https://podcast.easymedicaldevice.com/277-2/
Easy Medical Device* info@easymedicaldevice.com
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News April 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you how to do this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field.
Who is Cesare Magri? Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Linkedin Post High Quality Survey: https://www.linkedin.com/posts/cesare-magri_mdr-ivdr-clinicalinvestigation-activity-7173590917466042368-cFdG/ * Linkedin Post User Survey: https://www.linkedin.com/posts/cesare-magri_mdr-ivdr-survey-activity-7175785619837595648-aRxY
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to benefit from Surveys to build Clinical Evidence? appeared first on Medical Device made Easy Podcast. hamza benafqir
The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified.
Who is Steve Curran? Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and leader developing medical devices but also as a Notified Body regulator ensuring that devices are compliant when they reach the market. He has a broad range of experience from general medical devices to orthopaedic and dental devices and combination devices incorporating drugs and biologics.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Steve’s LinkedIn: https://www.linkedin.com/in/stephencurran/ * Blog on PMS: https://www.trinzo.com/medical-device-pms * PMS Training: https://www.meddevsolutions.co.uk/course/pms-training * Trinzo Website: www.trinzo.com * Trinzo LinkedIn: https://www.linkedin.com/company/trinzo
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to do Postmarketing Surveillance the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir
The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution?
Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR.
Who is Naveen Agarwal? Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Naveen Agarwal Linkedin Profile: https://www.linkedin.com/in/naveenagarwal/ * Learn more about Let’s Talk Risk! here ans subscribe: https://naveenagarwalphd.substack.com/about * Webinar recording – Getting Ready for QMSR: https://naveenagarwalphd.substack.com/p/webinar-5-getting-ready-for-qmsr * Risk management training on ACHIEVE: https://www.achievexl.com/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Learn more about FDA QMSR alignment with ISO 13485 appeared first on Medical Device made Easy Podcast. hamza benafqir
EU* EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/ * Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf * Spain: AEMPS consultation – Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/ * EURL Second Call – More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en * TEAM-NB Position Paper – Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/03/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf * EMDN Proposal – Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/ + MDCG 2024-2 : https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf * Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf
Training* Training Green Belt EU MDR – Learn by practicing: https://school.easymedicaldevice.com/course/gb30 + Open March 25th, 2024 until March 29th, 2024 * TEAM-NB Training – Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdf + April 29th, 2024
Services* Packaging and IFU – Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/
ROWUSA* Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device
CANADA* Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html + Draft Guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device.html
Mexico* Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es
Saudi Arabia* SFDA Harmonized Standards – Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf
Qatar* Qatar Telemedicine – Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf
Australia* TGA SOPP requirements – System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf * TGA Essential Principles – Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf * Transition to EU MDR cases – Evidence of transition, DCR, Non-Compliance, Recalls: + https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf + https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf + https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf + https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf
PODCAST* Episode 271 – How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/ * Episode 272 – Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/ * Episode 272 – New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/
EASY MEDICAL DEVICE Services:* Training: https://school.easymedicaldevice.com/emd-course/ * Authorized Representative EU: https://easymedicaldevice.com/eu-rep/ * Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/ * Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/ * Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/ * Eqms SmartEye; https://smart-eye.io * Conferences: https://medtechconf.com/
The post Medical Device News March 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
In January 29th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR transition periods. So apparently this is urgent and needed to avoid shortage. Let’s ask Erik Vollebregt what he thinks about it. Will this really help and when will this become a law as it is only a proposal for now.
Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ * Axon Lawyers Website: https://www.axonlawyers.com/ * Erik Blog: https://medicaldeviceslegal.com/ * Linkedin post: https://www.linkedin.com/posts/erikvollebregt_medical-devices-council-endorses-new-measures-activity-7166021646573641730-abCh * Medical Devices: Council endorses new measures to help prevent shortage: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/?utm_source=dsms-auto&utm_medium=email&utm_campaign=Medical+devices%3a+Council+endorses+new+measures+to+help+prevent+shortages * Proposal text: https://data.consilium.europa.eu/doc/document/ST-6156-2024-INIT/en/pdf
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post New EU Proposal – EUDAMED, IVDR & Shortage appeared first on Medical Device made Easy Podcast. hamza benafqir
When you are willing to sterilise your Medical Devices, you maybe think of EtO or Ethylene Oxyd as the method. So if you are on that case, there is a potential change that will happen and we want to alert you about that.
Christina Ziegenberg from BVMed is answering my questions and will explain to us the situation. So don’t miss this episode.
Who is Christina Ziegenberg? Dr. Christina Ziegenberg can look back on a distinguished career in medical technology, the chemical industry and pharmacy. With an education at the HBLVA for Chemical Industry in Vienna, a diploma in pharmacy at the University of Vienna and a doctorate at the Private University of Liechtenstein (UFL), she has held management positions at Hilti Aktiengesellschaft, the Liechtenstein State Administration and most recently at BVMed, where she holds the position of Deputy Managing Director / Head of the Regulatory Affairs Department.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* BVMed website: www.bvmed.de * BVMed link: https://www.bvmed.de/de/english/bvmed-services?pk_campaign=tsr_CHK&pk_kwd=english_tsr-aktuelles-gT_mi_bvmed-services * Current BVMed Position Paper in German: https://www.bvmed.de/download/positionspapier-ethylenoxid * BVMed Position Paper with regards to the public consultation: https://www.bvmed.de/download/bvmed-positionspapier-ethylenoxid-einstufung-nach-biozidverordnung-bpr * Information regarding EtO from ECHA: https://echa.europa.eu/de/information-on-chemicals/biocidal-active-substances/-/disas/factsheet/1304/PT02 * Assessment report: https://echa.europa.eu/documents/10162/3e7d946a-6939-2f2e-252e-dcd03d9ea36e * BPC Opinion: https://echa.europa.eu/documents/10162/5a3831c0-e6d4-7140-1e1b-2c8e3369edd4
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Will EtO gaz become a Medical Device? appeared first on Medical Device made Easy Podcast. hamza benafqir
You are maybe about to take a new job and you find out this episode of the podcast on how to prepare for an interview. I must say that we have invited the expert in recruitment for Medical Devices Elena Kyria from Elemed.
She will give you all the hints, tips to make your interview a success. So don’t miss this episode and don’t forget to raise your comments on the show notes.
Who is Elena Kyria? Elena Kyria is an award winning talent acquisition specialist, and CEO of Elemed. Elemed helps companies hire exceptional talent, and helps top QA/RA talent reach brilliant companies. She also coaches and supports top talent on how to build a strong professional brand, to help maximise career possibilities, and leads an executive podcast “career diaries in medtech” designed to inspire the next generation of medtech professionals
Who is Monir El Azzouzi?Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Elena Kyria LinkedIn Page: https://www.linkedin.com/in/elenakyria/ * Elemed Website: https://www.elemed.eu/ * Linkedin Post: https://www.linkedin.com/posts/elenakyria_pushpull-factors-job-interviews-activity-7161295184008257536-w-ub * Elemed Linkedin page:https://www.linkedin.com/company/elemed/ * Youtube: https://www.youtube.com/channel/UCZmfrYKQd8T7EpJ96zLbkRg * Career Diaries by Elemed: https://elemed.buzzsprout.com/ * Elemed tiktok: https://www.tiktok.com/@elemedteam * Elemed Instagram: https://www.instagram.com/elemedteam/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to get your interview prepared? appeared first on Medical Device made Easy Podcast. hamza benafqir
EU Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF + Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf + Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_24_347/QANDA_24_347_EN.pdf + Factsheet: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-factsheet_1.pdf * MDCG 2024-1 Vigilance System for CE – Guidance and Template: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf + MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf + MDCG 2024-1-2 Coronary Stents and associated delivery systems: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf + MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf + MDCG 2024-1-4 Breast Implants: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf * Language requirements for Manufacturers (MDR & IVDR) – Check where English is not applicable:* + MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf + IVDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf
eQMS your eQMS SmartEye – The best eQMS ever:* https://eqms-smarteye.com
UK Future Regulation roadmap – We still have to wait:* https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf
Course Training EU MDR Green Belt – February and March 2024* : https://school.easymedicaldevice.com/gb/
Notified Bodies and Approved Bodies UK Approved bodies – They are 9 now*: https://www.gov.uk/government/news/mhra-announces-two-new-uk-approved-bodies-to-certify-medical-devices + LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf + Scarlet NB UK: https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf
GDP video Good Documentation Practices – Check how to be sure to have good documents*: https://www.youtube.com/watch?v=nkBpef5AstI
ROW USA + US FDA Quality Management System Regulation – Alignment to ISO 13485: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked + US FDA IVD Reclassification – Move from Class III to Class II: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds + FDA Remote Regulatory Assessment (RRA) – Question and Answers: https://www.fda.gov/media/160173/download + Estar 5.1 version -: IVD and non-IVD: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program - Non-IVD: https://www.fda.gov/media/174458/download?attachment - IVD: https://www.fda.gov/media/174459/download?attachment - eStar 5.0 video with Rob Packard: https://www.youtube.com/watch?v=KDkKnRnBfgc * Saudi Arabia + Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262 + Manufacturing Devices at Point of Care (PoC) – uidance on how to manufacture them*: https://www.sfda.gov.sa/sites/default/files/2024-01/MDS%20–%20G009E.pdf
Events Medtech Conf – RAPS Workshop – Feb 27th until March 1st*: https://medtechconf.com/event/raps-events/
Podcast Nostalgia – Relisten again and again
- Episode 267 – Warning! Apply to your Notified Body Now! with Pritam Mekala: https://podcast.easymedicaldevice.com/267-2/
- Episode 268 – You are not the Physical Manufacturer, can you be MDR certified: https://podcast.easymedicaldevice.com/268-2/
- Episode 269 – Why you should use Pre-Submission or Q-Sub with FDA: https://podcast.easymedicaldevice.com/269-2/
Whatsapp Community: Whatsapp community – Register even if it says no*: https://chat.whatsapp.com/DvpnuGLihD98zGXsiYicQq
The post Medical Device News february 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
We always have a problem to contact regulators to ask them if our strategy is correct. In Europe, you cannot do that with a Notified Body unless you apply with one first and they cannot provide you with advice but just agree or disagree on your plan. Is it the same with the FDA. They have a specific pathway called Q-sub or Pre-Submission and you’ll see that this may be your Superpower to accelerate your success with your FDA application. Let’s listen to Saad Attiyah who will explain what is Q-SUB.
Who is Saad Attiyah? Experienced Regulatory Affairs and Quality Assurance professional with 20+ years of experience in medical devices, in-vitro diagnostics, human/cell tissue products, and combination device/drug products. Proven experience with U.S., Canadian, and E.U. Regulators, submissions, and Global Strategy Development. Extensive experience authoring U.S. 510(k)’s, E.U. MDR Technical Documentation, HDE Supplement, HDE/PMA Change Assessments for Supplements, Letters to File, Q-Submission, and Canadian New Submission/Amendments. Certified Lead Auditor, QMS Expert, and Warning Letter Remediation.
Areas of specialty: New Product Development Strategy for Global Markets, Maintenance and remediation of existing devices, clinical evaluation reports/trials, and compliance activities, QA/QC, SOP development.
Device Types: Capital equipment and consumables such as blood analyzers and reagents, sterilizers and sterilant, ventilators, aspirators, centrifuges, implantable devices, single use medical devices, reusable instruments, and thermometry devices.
Device Classifications: US I through III, Canada Class II through IV, E.U. Class I through Class III, Compassionate Use
510(k): K072866-Spinal Fixation System, K080281- Interbody Fusion Device, K090566- Novel Interbody Fusion Device, K091134- Anterior Cervical Plating, K092904 -Vertebral Body Replacement Device, K111009- Spinal Fixation System, K111774- Interbody Fusion Device, K153379- Orthopedic Plating, K161863- Shoulder Arthroplasty Devices w/expanded indications, K181091- Orthopedic Plating w/ Pediatric Indications.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Saad Attiyah LinkedIn: https://www.linkedin.com/in/saadattiyah * US FDA QSUB guidance : https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Why you should use Pre-Submission or Q-Sub with FDA? appeared first on Medical Device made Easy Podcast. hamza benafqir
Who is Adam Isaacs Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video:* Profile LinkedIn: https://wwwhttps://www.linkedin.com/in/adam-isaacs-rae/.linkedin.com/in/ * Useful Documents: https://www.gov.uk/government/publications/medical-devices-virtual-manufacturing-replaces-own-brand-labelling/virtual-manufacturing-of-medical-devices * Virtual Manufacturer : Commission Recommendation 2013/473/EC. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:253:0027:0035:EN:PDF
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post You are not the Physical Manufacturer, can you be MDR certified? appeared first on Medical Device made Easy Podcast. hamza benafqir
Medica 2023 was really a great event and I am please to provide you here with a summary and interviews with multiple actors. You’ll see that this is so diverse. We met with Startups, Service Providers, Notified Bodies and asked them the questions you would like to ask. So don’t miss this opportunity first to understand what is MEDICA and second to hear what Notified Bodies are saying for example.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video* linkedin Abhinav Jain: https://www.linkedin.com/in/4abhinavjain/ linkedin Diego * linkedin Stevanella:https://www.linkedin.com/in/diego-stevanella-25605310b * linkedin Anindya Mookerjea: https://www.linkedin.com/in/anindyamookerjea * linkedin Alessia Frabetti : https://www.linkedin.com/in/alessia-frabetti-6746465b/ * linkedin ADNAN ASHFAQ :https://www.linkedin.com/in/adnan-ashfaq-44478121/ * linkedin Stuart Angell: https://www.linkedin.com/in/stuartangellivd/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies… appeared first on Medical Device made Easy Podcast. hamza benafqir
The EU MDR 2017/745 was extended but does this change something for you? Do you need to apply to your notified body later? What can be the promise made by your Notified Body? Can they advice you? Pritam from TÜV SÜD will be answering my question without any taboo. So don’t hesitate also to go to the show notes and see his details as at the end of the video he will be making you a promise. So don’t miss this opportunity.
And if you need some support for your Notified Body application contact us at Easy Medical Device.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Who is Pritam Mekala? Pritam Mekala is an enthusiastic, ambitious, and motivated medical device expert. Born in India, grew up in America, studied in the US, and currently living and working in Toronto, Canada, Pritam is an ensemble of multi-national, multi-cultural and multi-linguistic personality. He currently works at TÜV SÜD, as a Product Expert & Auditor in their Medical Health Sciences (MHS) Product Assessment Team (PAT).
Before joining the Notified Body team, Pritam worked as a was project engineer at Abbott on their infamous BinaxNOW – COVID Test Kit project. He also worked at other notable medical device manufacturers such as Medtronic, Covidien, Zimmer Biomet etc.
On the education front, Pritam graduated from the Oklahoma State University with a master’s in mechanical and aerospace engineering with research & specialization in Biomedical Engineering.
As a representative of Notified Body, TÜV SÜD, Pritam can help you facilitate:
- Free 30minute Call (at no additional cost) NOT CONSULTATION
- Free Budgetary quote (for review & comparison)
- Free Technical Documentation Guidance (at no additional cost)
Links from the Video* Profile LinkedIn: https://www.linkedin.com/in/pritam-mekala/ * Email: Pritam.mekala@tuvsud.com * Company website: https://www.tuvsud.com/en-us * Relevant MDCG Announcements: * https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf * https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf * https://health.ec.europa.eu/latest-updates/mdcg-2022-14-transition-mdr-and-ivdr-notified-body-capacity-and-availability-medical-devices-and-2022-08-26_en * TÜV SÜD Structure Dialogue: * https://ts.tuvsud.com/rs/819-PVY-502/images/T%C3%9CV%20S%C3%9CD%20Structured%20Dialogue%20-%20customer%20presentation.pdf?version=0&mkt_tok=ODE5LVBWWS01MDIAAAGO-2Fg5uIG2idWOUuPQkEspBBKLOHU1vf9rLoMqzR2t_pnXJguMMpidTQA5rQbAJ-uIcPpYp3S4QS8SV6R1wE2GeN8IJNMyV2HJf24YyQdGxo
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post WARNING! APPLY TO YOUR NOTIFIED BODY NOW! appeared first on Medical Device made Easy Podcast. hamza benafqir
Medboard
Who is Medboard
- Medboard: https://www.medboard.com/
EU
EU Reference laboratories EURL
- EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713
- Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-12-06_en
Letter to EU Parliament
Letter sent to the European Parliament – Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INIT
MDCG 2023-7 on Clinical Investigation
- MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf
MDCG 2019-07 rev 1 on PRRC
- MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf
MDCG 2021-27 on Importer and Distributor
MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf
MDCG 2023-5 on Annex XVI class
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf
MDCG 2023-6 on Annex XVI Equivalency
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf
Companion Diagnostics CDx
EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf
Switzerland
Guidance on Devices with no medical purpose
- Medical Device without Medical Intended Purpose: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf
Emergency use of non-conform device
- Exemption to Medical Device non-conforming: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw617_00_003d_mb-ausnahmebewilligung-mep.pdf.download.pdf/BW617_00_003e_MB%20Derogation%20MEP.pdf
Notified Bodies:
New Notified Body under EU MDR
43rd NB MDR – CESKY METROLOGICKY INSTITUT – Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true
Notified Body Situation
- Notified Body Situation; https://health.ec.europa.eu/system/files/2023-12/notifiedbodies_overview_en.pdf
Training:
EU MDR training
- Green Belt training
- 28th edition January 22nd until 28th https://school.easymedicaldevice.com/course/gb28/
- 29th edition February 19th until 23rd https://school.easymedicaldevice.com/course/gb29/
- 30th edition March 25th until 29th https://school.easymedicaldevice.com/course/gb30/
Medical Device e-Training
- eTraining
- Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
ROW
- Mexico:
- Mexico registration rules
Guide for obtaining the Health Registry of Medical Devices – https://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/
- Brazil:
- Brazil is calling Innovative Medical Devices
- Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/dispositivos-medicos-inovadores-anvisa-prorroga-prazo-de-participacao-em-projeto-piloto
- Hong-Kong:
- Hong-Kong Guidances
- Artificial Intelligence Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR008.pdf
- Software Medical Devices and Cybersecurity: https://www.mdd.gov.hk/filemanager/common/mdacs/TR007.pdf
- Guidance note for Listing Class II/III/IV General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
- Guidance note for Listing Class B, C, D In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf
- Classification of In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf
- USA:
- USA Export documents transition to digital
- Transition to Electronic Export Documents – Letter to Industry: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry
- India:
- India New platform to register
- National Single Window System (NSWS) Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTA=
- Australia:
Australia Boundary and Combination products
guide on boundary and combination products https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf
- Australia on Custom-Made and Patient Match
- How to submit a custom-made medical device / patient-matched medical device notification: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
- Malaysia
- Malaysia is telling rules on Borderline products
- Harmonised borderline products in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-borderline-products-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWJvcmRlcmxpbmUtcHJvZHVjdHMtaW4tYXNlYW4tc2Vjb25kLWVkaXRpb24tMi1wZGYiLCJpYXQiOjE3MDIzNDcxOTksImV4cCI6MTcwMjQzMzU5OX0.4cNrbv3GpbG2KjL6uQxcxm3KeBGLsxZy77JqQKiIXUc
- Malaysia is telling rules for classification of products
- List of harmonized classification of Medical Devices in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-classification-of-medical-device-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWNsYXNzaWZpY2F0aW9uLW9mLW1lZGljYWwtZGV2aWNlLWluLWFzZWFuLXNlY29uZC1lZGl0aW9uLTItcGRmIiwiaWF0IjoxNzAyMzQ3MTk5LCJleHAiOjE3MDI0MzM1OTl9.WbMya1V8vykQ88aQyqpraMR4G7rZ_QA36hN_DOEeqso
Podcast Nostalgia
Podcast Nostalgia
- Episode 262 – What is usability: https://podcast.easymedicaldevice.com/262-2/
- Episode 263 – Why you should invest in your Regulatory Team: https://podcast.easymedicaldevice.com/263-2/
- Episode 264 – Life of a QA RA Podcaster https://podcast.easymedicaldevice.com/264-2/
- Episode 265 – Heatmap: https://podcast.easymedicaldevice.com/265-2/
The post Medical Device News – january 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
This presentation was recorded during MEDICA COMPAMED 2023. Stefan Bolleininger from Be on Quality did share with us the information about HEATMAP for Regulatory Affairs. The idea is mainly to be able to improve the visualisation of a certain state of your department or project. There will be the collection of data, the scoring, then the creation of the heatmap, the colour coding, the visualization, and analysis/actions.
So, if you want to find a refreshing way to present the situation of your projects, don’t hesitate to learn this with this presentation. And download the presentation within the link below.
Who is Stefan Bolleininger? Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Stefan Bolleininger LinkedIn Page: https://www.linkedin.com/in/stefan-bolleininger-3a717028/ * Be on quality website: http://www.be-on-quality.com/en/home-en/ * Download presentation: https://mailchi.mp/easymedicaldevice/265-heatmap * Medica Website: https://www.medica-tradefair.com/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Regulatory Maturity Model – Heatmap (MEDICA 2023) appeared first on Medical Device made Easy Podcast. hamza benafqir
Easy Medical Device has its podcast and many other Quality and Regulatory Affairs people are also doing podcasting. I have met with Claudia and Jorg who are also having a podcast and we reviewed our experience and encouraged people to also start their podcast. Check our experience and learn from it.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Claudia Dannehl Linkedin Profile: https://www.linkedin.com/in/claudia-dannehl/ * Jorg Brokmann Linkedin Profile: https://www.linkedin.com/in/j%C3%B6rg-brokmann-051438249/ * Podcast Spotify: https://open.spotify.com/show/1H9MS4y7RmDQsDxM4DfDow?si=3e6b684150c049d1
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Life of QA RA Podcasters? appeared first on Medical Device made Easy Podcast. hamza benafqir
Regulatory affairs teams have an outsized impact on business revenue, bringing new products to market quickly, managing registrations and licenses to keep products on the market, and staying updated on changing standards and regulations that might impact market clearance. Yet most regulatory affairs teams are treated primarily as operational cost-centers, resulting in poor productivity measurement, unclear objectives, and limited investments in people and technology.
During this podcast episode, we’ll discuss why medtech companies should invest in their regulatory teams
Who is James Gianoutsos? James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software, a cloud-based solution to digitize, automate, and create regulatory order for MedTech companies. James is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. His professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. James also has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, MDR, MDSAP, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* James Gianoutsos LinkedIn: https://www.linkedin.com/in/jwgianoutsos/ * Rimsys website: https://www.rimsys.io/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Why should you invest in your Regulatory Team? appeared first on Medical Device made Easy Podcast. hamza benafqir
The Medical Device field is so big that we have a specialist for each type of area. This is like a Surgeon that is specialist of the heart, the orthopaedic… Here we have with us a specialist for Usability, and this is really a big filed that you need to understand. IEC 62366 is a standard that is important to know as all devices that have a user interface should show they can be safe, and that user understands it. So, don’t miss this episode.
Who is Michael Engler? Senior Consultant, Managing Partner at Benkana Interfaces GmbH & Co. K
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Michael Engler LinkedIn Page: https://www.linkedin.com/in/michael-engler-benkana/ * Benkana Interface website: https://www.benkana-interfaces.com/
The post What is Usability for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
Medboard* Medboard platform Sponsor of the podcast https://www.medboard.com/
EU* EPSCO Meeting November 30th. 2023 – MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf * Survey on Medical Devices – Study supporting the monitoring of the availability of Medical Devices on the EU Market. + Information: https://ec.europa.eu/eusurvey/runner/MFandAR + Questionary: https://ec.europa.eu/eusurvey/files/6a4fd4cd-dfce-4fe1-bcaf-9f44eb00e471/650fed06-30d2-40b1-9ff0-e96c79b4eb96 * Falsification of Medical Devices – Survey result: https://act.edqm.eu/s/XcPw5MDtYe49gmj/download/CMED-Survey-Report-Final%20%281%29.pdf * MDCG 2022-11 Rev 1 Position Paper – Call to NB to streamline the certification process https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf * EU IVDR Technical Documentation training – TEAM-NB Survey result + Training IVDR technical documentation February 1st, 2024: https://www.team-nb.org/wp-content/uploads/2023/11/Leaflet-IVD-TD-Manufacturers-Training-20240201.pdf + Result on Survey of MDR training: https://www.team-nb.org/mdr-technical-documentation-training-for-manufacturers/ * DEHP Substance forbidden in Medical Devices – Extension to July 1st, 2030 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482 * Notified Bodies Situation – 2 new comers: + UDEM Turkey 41st NB under MDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7 + Scarlett NB B.VC. 42nd NB under MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=2feeb6d10d338167081ad0cf7af6683fe760cded&group=NOTIFICATION&download=true
Switzerland* Vigilance Reporting submission information – Update your QMS procedures: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/uebersicht-medizinprodukte/archiv/hinweis-einreichung-vigilance-meldungen-mep.html
Training EU MDR* Training EU MDR 2017/745 – December 11th – Green Belt Certification Program for EU MDR : https://school.easymedicaldevice.com/course/gb27
Medtech Conf* Your Medtech Conferences – Register all your Events, Training, Conferences: https://medtechconf.com/
USA* FDA withdrawal – not anymore member of the GHWP: https://www.fda.gov/media/174142/download * Discontinuation in the USA – Notifying FDA of a permanent discontinuation: https://www.fda.gov/media/155245/download * Webinar on Companion Diagnostics – Oncology Drug Products used with IVD tests: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program-12122023
Canada* Medical Device Establishment Licenses annual review – You should receive your Christmas Package: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2024.html
Saudi Arabia* Webinar: Clinical Trials of Medical Device Requirements – Click on the link in December 12th, 2023: https://www.sfda.gov.sa/en/workshop/93098
South Africa* Guideline on Q&A for Licensing of Medical Device Establishment – Learn how to start this activity: https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf
Brazil* Argentina & Brazil signed a Mutual Recognition Agreement – For certificates for Medical Devices: https://www.argentina.gob.ar/noticias/anmat-y-anvisa-firmaron-el-primer-acuerdo-de-reconocimiento-mutuo-en-certificados-para
SmartEye* eQMS for Medical Device companies – Get your Demo now: https://smart-eye.io
Podcast Nostalgia * How to CE certify a calculator, risk score software as Medical Device? Cesare Magri: https://podcast.easymedicaldevice.com/258-2/ * How to find a predicate Device for your 510k submission? Beat Keller: https://podcast.easymedicaldevice.com/259-2/ * What is the situation regarding Digitalization in the Medtech industry? MedXD https://podcast.easymedicaldevice.com/260-2/
Easy Medical Device support – info@easymedicaldevice.com
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News: December 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
Don’t miss this panel discussion that happened during the MEDXD in Berlin (26 and 27 September). Medical Device companies are moving to digitalize their processes and MDKU association did create the MEDXD conference where the discussions from multiple companies helped to understand the status.
Monir El Azzouzi moderated this panel and asked questions following the presentation that were provided.
This panel discussion was composed of1. Karim Djamshidi 1. Vice President Global Patient Health & regulatory Compliance, Karl Storz https://www.linkedin.com/in/karim-djamshidi/ 2. Denise Wocko * Head of Global Client Portfolio Management, RQM+ * https://www.linkedin.com/in/denisewocko/ 3. Sarah Haake-Schäfer * Head of Quality Management, Regulatory & Clinical Affairs, Carl Zeiss Vision https://www.linkedin.com/in/sarah-h-981a94226/ 4. Markus Pöttker * PMS Lead – Safety & Surveillance, Smith + Nephew, https://www.linkedin.com/in/markuspoettker/ 5. Sarah Panten * Managing Partner / Strategic Business & Product Development, avasis * https://www.linkedin.com/in/sarahpanten/
Who is Monir El Azzouzi?Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:* MEDXD link: https://medtechx.digital/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What is the situation regarding digitalization in Medtech? appeared first on Medical Device made Easy Podcast. hamza benafqir
The choice of a Predicate Device is important and challenging at the same time. Your predicate device is already on the US market, so all you must do is select it and confirm that your device is the same as the predicate and Bingo, you can register your product in the US. But this is not as simple as that. Beat Keller from imt in Switzerland will share with us his experience working on US submissions and provide some hints on what you should or should not do.
Who is Beat Keller? Beat is the Head of Regulatory Affairs and Quality Management at IMT, a Swiss Consultancy and Engineering Service provider for medical device manufacturers. He has worked for more than 10 years in the medical device industry first as a software engineer, then as a project leader before he took over the Regulatory and Quality department of IMT.
Beat is also active in different standards working group as Co-Convenor of the “conformity assessment” working group of the Swiss standards association and member of different working groups on Swiss, European and International level for medical device standards.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/ * imt website: https://www.imt.ch/ * US FDA predicate device guidance: https://www.fda.gov/media/171838/download * MDCG Guidance on Equivalent Devices: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to find your Predicate Device for your 510K Submission? appeared first on Medical Device made Easy Podcast. hamza benafqir
We have a lot of sort of Software as Medical Devices. Today I wanted to ask to Cesare Magri some questions about APIs. First what they are, and can they be a Medical Device. He will also give us some advice on what to do if your API is really a medical device. So stay tuned.
Who is Cesare Magri? Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diagnostic manufacturers by leveraging clinical and non-clinical data for certification and marketing purposes. He has contributed to more than 100 clinical and performance evaluation for devices of all risk classes.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Links from the Video * ■ Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri/ * ■ 4BetterDevices website: https://4betterdevices.com/
Social Media to follow * ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * ■ Twitter: https://twitter.com/elazzouzim * ■ Pinterest: https://www.pinterest.com/easymedicaldevice * ■ Instagram: https://www.instagram.com/easymedicaldevice
The post How to CE certify a Calculator, Risk Score…? appeared first on Medical Device made Easy Podcast. hamza benafqir
EU: UDI for contact lenses Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197 * EUDAMED Roadmap It is a DRAFT: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf * MDCG 2023-4 guidance – Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf * Fees and charges payable to EMA: Expert Panel will cost you money : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_14057_2023_INIT * Notified Bodies :* Finland and Turkey + Sertio Oy (Finland) IVDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1001622 + Notice Belgelendirme (1st Turkish Notified Body) MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=82870fd17389fc19149f103e8121acdc82fea1af&group=NOTIFICATION + Team-NB call for action to Manufacturers to apply: https://www.team-nb.org/wp-content/uploads/2023/10/Team-NB-PressRelease-Capacity-NotifiedBodies-during-transition-IVDR-MDR-October2023.pdf
Training for youIncrease your knowledge in QA RA :
- Vigilance Reporting in EU: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
- Green Belt training: December 11th until December 15th: LINK
Spain: Implementation of the HTA :* EU Health Technology Assessment Regulations: https://www.aemps.gob.es/la-aemps/de-la-teoria-a-la-practica-implementacion-del-reglamento-de-evaluacion-de-tecnologias-sanitarias-de-la-ue/ * Regulation 2021/2282 on health technology assessment: https://health.ec.europa.eu/publications/regulation-eu-20212282-health-technology-assessment_en
Switzerland: Products without an intended medical purpose : Same as EU MDR: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf * Obligation Economic Operators –:* Update due to extension https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016e_MB_Obligations_Economic_Operators_CH.pdf * General procedure for foreign governmental inspections – Inform Swissmedic before governments audit a manufacturer https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/i-308/i-308_aa_02-A01e_general_procedure_for_foreign_governmental_inspections_switzerland.pdf.download.pdf/I-308.AA.02-A01e_Merkblatt_General_procedure_foreign_govern_insp_CH_related_therapeutic_prod.pdf
MedTech Conf Map of conferences available
- Conferences Map: https://medtechconf.com/
- Medica Dusseldorf November 13 -15 : https://medtechconf.com/event/medica-2023/
- TEAM-PRRC Strasbourg November 16 – 17: https://medtechconf.com/event/team-prrc-annual-summit-2023/
Turkey:* Product not considered as a Medical Device – List of products available: https://titck.gov.tr/duyuru/tibbi-cihaz-yonetmelikleri-kapsaminda-degerlendirilmeyen-urunler-30102023120556
eQMS SmartEye:* SmartEye is your eQMS – Ask for your DEMO : https://smart-eye.io/
USA: eStar is your new 510k :* Since October 1st, 2023: https://www.fda.gov/media/152429/download
Australia: Webinar on UDI for Australia –* November 21st, 2023 11.30 AEDT: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-udi-webinar-19-australian-udi-project-update-and-discussing-considerations-and-real-world-benefits-adopting-udi-healthcare
Podcast Nostalgia : You remember* What are some pitfalls to avoid during Software Design? Weronika Michaluk: https://podcast.easymedicaldevice.com/253-2/ * Affrisummit 2023 Part 1 Morad Ajan, Rana Chalhoub, Dr. Mona Al Moussali: https://podcast.easymedicaldevice.com/254-2/ * Afrisummit 2023 Part 2 Nora El-Hariri and Mohamed Mahdy Ghonim: https://podcast.easymedicaldevice.com/255-2/ * Validate your iPhone, Samsung Galaxy, Huawei for your Software Erik Vollebregt: https://podcast.easymedicaldevice.com/256-2/
The post Medical Device News – November 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
This MDCG came like evidence but comments on it where more confusion. What exactly was the objective of the MDCG 2023-4. We will try to explain to you on this podcast with Erik Vollebregt from Axon Lawyers.
Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links* ■Erik Vollebregt LinkedIn: https://www.linkedin.com/in/erikvollebregt/ * ■Axon Lawyers website: https://www.axonlawyers.com/ * ■MDCG 2023-4: https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf * ■Blog post: medicaldevicelegal.com * ■Book: https://erikvollebregt.gumroad.com/ * ■Blue guide: https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en
Social Media to follow * ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * ■ Twitter: https://twitter.com/elazzouzim * ■ Pinterest: https://www.pinterest.com/easymedicaldevice * ■ Instagram: https://www.instagram.com/easymedicaldevice
The post Validate your Iphone, Samsung Galaxy, Huawei… for your Software appeared first on Medical Device made Easy Podcast. hamza benafqir
The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders. This is the part 2 where we will focus on the Egypt situation.
Check Part 1 for the first interviews with (https://podcast.easymedicaldevice.com/254-2/):
- – Morad Ajan – Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) – Morocco
- – Rana Chalhoub – Regulatory Affairs Director at Mecomed.
- – Dr. Mona Al Moussali – Co-founder PRA Consultancy and organizer of the Afrisummit.
In this part 2 we have:
- – Noha El-Hariri – Head Regulatory Affairs Medical Device
- – Mohamed Mahdy Ghonim – IVD Manufacturer in Egypt
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link * ■ Noha El-Hariri LinkedIn Page: https://www.linkedin.com/in/noha-el-hariri-a46a1285/ * ■ EDA Webpage: https://www.edaegypt.gov.eg/ * ■ Mohamed Mahdy Ghonim LinkedIn Page: https://www.linkedin.com/in/mohamed-ghonim-1444102b/ * ■ Mohamed Mahdy Ghonim Qualitech International: https://www.qt-int.nl/ * ■ Thequa medical: https://www.thequa-med.com/ * ■ Afrisummit: https://www.linkedin.com/company/pharmaregafrisummit/
Social Media to follow * ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * ■ Twitter: https://twitter.com/elazzouzim * ■ Pinterest: https://www.pinterest.com/easymedicaldevice * ■ Instagram: https://www.instagram.com/easymedicaldevice
The post Afrisummit 2023 Interviews Part 2 – Egypt Situation appeared first on Medical Device made Easy Podcast. hamza benafqir
The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders.
First, I have the interview with Morad Ajan – Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) – Morocco. We reviewed the Quality and Regulatory situation of Morocco and learned a lot of good information about progress that the authorities are ongoing to be modernized.
Second, we have the interview with Rana Chalhoub – Regulatory Affairs Director at Mecomed. We reviewed the situation in Middle East and Africa and why a summit like Afrisummit is important.
Third, the interview with Dr. Mona Al Moussali – Co-founder PRA Consultancy and organizer of the Afrisummit. We reviewed how the summit went and what are some feedback out of it.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link * Morad Ajan LinkedIn Page: https://www.linkedin.com/in/ajanm/ * DMP website: https://dmp.sante.gov.ma/ * Rana Chalhoub LinkedIn Page: https://www.linkedin.com/in/rana-chalhoub-8a391214/ * Mecomed website: https://www.mecomed.com/ * Dr Mona Al Moussali LinkedIn Page: https://www.linkedin.com/in/mona-almoussli/ * PRA Consultancy Website: https://pra-me.com/ * Afrisummit: https://www.linkedin.com/company/pharmaregafrisummit/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Afrisummit 2023 Interviews Part 1 appeared first on Medical Device made Easy Podcast. hamza benafqir
More and more companies are starting to develop Software as Medical Devices (SAMD) and in this podcast episode, I have invited Weronika Michaluk to talk to us about some pitfalls that you need to avoid.
Weronika will talk about: * – Risk Management * – Usability * – Documentation * – Expertise * – Interoperability and scalability * – Cybersecurity.
So don’t miss that and don’t hesitate to contact Easy Medical Device if you have some questions.
Who is Weronika Michaluk? Weronika Michaluk is an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. She is a Biomedical Engineer by training, holds a Master’s degree in International Business from the University of Miami, an MBA from the Warsaw School of Management, and a Doctorate in Public Health (DPH) with a specific focus on the business strategy of Agile Development of Software as a Medical Device (SaMD). Weronika’s career began as a Biomedical Engineer, where she contributed to the development of various biomedical devices, including a wireless ECG system, then she worked in South Korea in the Neuroscience Department and after that she focused on digital health solutions and consulting in the medical device space.
Currently, Weronika serves as the Digital Health Principal and SaMD Lead at HTD. In this role, she leads the Software as a Medical Device department, utilizing her expertise in biomedical engineering and business acumen. Her primary objective is to ensure that all products are meticulously designed and developed, adhering to the highest quality standards. Weronika’s dedication to customer satisfaction and patient safety is instrumental in driving the success of the organization and its customers.
In her free time Weronika enjoys learning new languages (speaks 5 currently), travelling the world, playing sports, hiking ( she recently hiked Kilimanjaro, plans to hike to Mount Everest base camp next year) and discovering the unknown.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link* Weronika Michaluk LinkedIn Page: https://www.linkedin.com/in/weronika-michaluk-mba-43811698/ * HTD Health website: https://htdhealth.com/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What are some pitfalls to avoid during Software Design? appeared first on Medical Device made Easy Podcast. hamza benafqir
EU Manual on Borderline and classification for Medical Devices Update – New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf * Q&A on Annex XVI Products – Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf * Italy: Custom-made medical device registration– Specific website available: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6352 * Ireland: Custom-made device Webinar October 19th, 2023 – Webinar to join: https://www.hpra.ie/homepage/medical-devices/news-events/item?t=/custom-made-device-(cmd)-regulation-webinar&id=5ad21426-9782-6eee-9b55-ff00008c97d0 * Team-NB – Training on MDR Technical Documentation for Manufacturers –* Date of the event November 7th, 2023: https://www.team-nb.org/new-team-nb-initiative-mdr-technical-documentation-training-for-manufacturers/ + Technical Documentation template Premium Pack: https://school.easymedicaldevice.com/product/eu-mdr-technical-file-premium-pack/ * FIMEA designate first Notified Body under the IVD regulation in Finland – EUROFINS Electric & Electronics Finland Oy: https://www.fimea.fi/web/en/-/fimea-designates-the-first-notified-body-under-the-ivd-regulation-in-finland
UK* The innovation Devices Access Pathway (IDAP) – Pilot Phase to join – Answer before October 29th, 2023: https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase
CH* Swissdamed Survey Report – The EUDAMED for Switzerland to start in 2024: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/survey-results-report.pdf.download.pdf/20230919_swissdamed_survey%20results%20report.pdf
ConferencesWhich conferences to focus on? -I will be going to them so join me.
- MEDXD: Digitalisation of Medtech: https://medtechx.digital/
- Afrisummit in Egypt: https://www.pharmaregafrisummit.com/
- Medica: https://www.medica-tradefair.com/
- Team-PRRC: https://www.team-prrc.eu/
Training Trainings for you – Self-paced
- Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
US* US FDA – De Novo Request – Electronic Submission template: https://www.fda.gov/media/172450/download * Webinar US FDA – Cybersecurity in Medical Devices: – November 2nd 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-cybersecurity-medical-devices-quality-system-considerations-and-content * Webinar US FDA – Breakthrough devices program update – November 14th, 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-breakthrough-devices-program-updated-final-guidance-11142023 * Digital Health FAQ – Is your medical device an SaMD?: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs * ISO 10993-1:2018 versus FDA – FDA is adding its touch: https://www.fda.gov/media/142959/download * Best practice for selecting a Predicate device for your 510K – Method provided. https://www.fda.gov/media/171838/download
Saudi Arabia SFDA Significant changes guidance –* Template inside: https://www.sfda.gov.sa/sites/default/files/2023-09/MDS-G12a.pdf
Malaysia Malaysia: Workshop preparation of documents for Submission –* October 23rd, 24th and 30th: https://www.mda.gov.my/announcement/1285-first-announcement-hands-on-workshop-efficient-way-to-prepare-for-mda-documentation-submissions.html
Turkey* Mutual Recognition of Authorized rep and NB in Turkey – Good clarification: https://titck.gov.tr/duyuru/tcokka-mutual-recognition-of-authorized-representatives-and-notified-bodies-in-the-field-of-medical-devices-between-the-eu-and-turkiye-19092023160242
Japan* Japan: Essential Principles – In 2023 inclusion of the Cybersecurity risks: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/MHLW_Notification_122_of_2005.pdf
India* India: List of registered medical device testing laboratory – under Indian mdr 2017: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1MTE=
PodcastPodcast Nostalgia – Do you remember?
- Episode 249: Team-PRRC interviews part 1 : https://podcast.easymedicaldevice.com/249-2/
- and 250: part 2: https://podcast.easymedicaldevice.com/250-2/
- Episode 251: EUDAMED Updates: https://podcast.easymedicaldevice.com/251-2/
QMS How Easy Medical Device can help you –easymedicaldevice.com
- We can also help you implement our eQMS – Smarteye: https://smart-eye.io
The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
EUDAMED is the European Database for Medical Devices. In this episode, Richard Houlihan will be my guest and will explain to us the situation regarding EUDAMED. For the moment this database is not finished, so should you use it? We will also review the timeline and help you understand what you should do now. Don’t miss that episode as EU MDR 2017/745 and IVDR 2017/746 ask you to register your company, your products in this database.
Who is Richard Houlihan? Richard Houlihan is an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions. His company EirMed with the website eudamed.com provides EUDAMED regulatory submission software solutions to help Manufacturers large and small including full project management, training, an EUDAMED mobile search app, and support to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations. To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Link: * Richard Houlihan LinkedIn: https://www.linkedin.com/in/richard-houlihan/ * EUDAMED.Com website: https://eudamed.com/ * EUDAMED database link: https://ec.europa.eu/tools/eudamed/#/screen/home * EUDAMED registration page: https://webgate.ec.europa.eu/eudamed/landing-page#/ * EUDAMED and Germany: https://www.bfarm.de/EN/Medical-devices/Overview/Europe-and-EUDAMED/_node.html * EMDN Code Website: https://webgate.ec.europa.eu/dyna2/emdn/ Meeting Minute EUDAMED timeline: https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=48063&fromExpertGroups=3565 * Playground: https://webgate.training.ec.europa.eu/eudamed-play
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What is the EUDAMED Updates? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this second part of this podcast series on Team-Prrc interviews. we have 3 additional guests. Don’t miss the first one where we also got great interviews. In this episode, we will interview
- Bassil Akra about the Team-PRRC event and why you should come. This will happen again on November 16th and 17th.
- Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company
- Elem Ayne, the Team-PRRC president will explain to us more about the event and how this first session went.
So don’t miss the next opportunity to meet everyone at the Team-PRRC event in Strasbourg – France on November 16th and 17th. You’ll be able to create a great network.
Links from the Video * Bassil Akra Linkedin: https://www.linkedin.com/in/bassil-akra-akrateam/ * Elena Kyria Linkedin: https://www.linkedin.com/in/elenakyria/ * Elem Ayne Linkedin: https://www.linkedin.com/in/elemayne/ * Team-PRRC Event: https://www.team-prrc.eu/page/1111392-presentation * Medical Device: All about the role of PRRC: https://www.youtube.com/watch?v=RCBYA1wLQLU
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Interviews on Being The PRRC (Part 2) appeared first on Medical Device made Easy Podcast. hamza benafqir
Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a PRRC within the different […]
The post Interviews on Being The PRRC first appeared on Medical Device made Easy Podcast.
The post Interviews on Being The PRRC appeared first on Medical Device made Easy Podcast. hamza benafqir
This month we will review all what happened in the Medical Device world during the last weeks and what will happen in the next weeks. Check that
The post MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update first appeared on Medical Device made Easy Podcast.
The post MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
Medical Devices that are reusable should be cleaned. But the user is not a professional of your product so he needs to receive some instruction on how to clean it. In this episode of the podcast we will explain to you what is cleaning validation and also talk about microbiology, electrical device cleaning, Notified Body issues…
So let’s listen to Enrico Allegra from TestLabs who will share with us his experience.
Who is Enrico Allegra?
Enrico has over 10 years of experience in regulatory microbiology combining environmental safety with clinical settings as a study director. He graduated with a Bachelor of Science degree in Immunology with Medical Microbiology followed by a master’s degree in Clinical Microbiology from Queen Mary University of London in 2013. During his previous role, he worked extensively in method transfer and development. His work spanned from environmental microbiology to clinical settings.
He worked on clinical trials to assess the validity of vaccination against Group B Streptococci in pregnant women.
He was strongly involved in the assessment of the safety of agrochemical products such as biocides as well as being the lead scientist for the assessment of antimicrobial susceptibility testing of pre and probiotic products. During his time working in safety assessment, he collaborated on a CRACK-IT sponsored research under the NC3Rs as the lead scientist.
The research focused on evaluating the discrimination of toxic and non-toxic chemicals using wax moth larvae Galleria mellonella as model to help reduce, replace, and refine the use of animal models.
The research was published for Chemosphere (Elsevier) in May 2018. During the height of the pandemic, he worked on the development of antiviral assays against Coronavirus as well as being part of clinical trial of bacteriophage technology to help fighting secondary infection of cystic fibrosis patients.
He is a certified biosafety officer and operates as the Head of Laboratory at Test Labs, a Medical Device testing laboratory. Enrico massively helped developing the facility from an empty canvas to a fully operational ISO 17025:2017 accredited laboratory, in less than 11 months. Leading the microbiology, chemistry and material sciences teams in performing Medical Device testing, he provides expert knowledge combining the experience in method validation and new method development to help customer with reliable and fully validated reports.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Links from the Video
■Enrico Allegra LinkedIn: https://www.linkedin.com/in/enrico-allegra-b97751164
■TestLabs LinkedIn Page: https://www.linkedin.com/company/testlabsuk/
■TestLabs webpage: https://testlabsuk.com/
Social Media to follow
■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice
We all are afraid of one thing. It is to see our Clinical Evaluation rejected by a Notified Body. Why? Because apparently EU MDR is creating a more restrictive environment for accepting what was acceptable before. So let’s review in this episode the acceptance criteria for your Clinical Evaluation and what kind of surprises you would maybe discover all along the way. For that I have invited Cesare Magri from 4BetterDevices to help us understand this pathway and take the right road at the crosses.
Who is Cesare Magri?
Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:
-Cesare Magri Linkedin : https://www.linkedin.com/in/cesare-magri/ 4BetterDevices
-LinkedIn Page: https://www.linkedin.com/company/4betterdevices/
-Website 4BetterDevices: https://4betterdevices.com/
Social Media to follow
-Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
-Twitter: https://twitter.com/elazzouzim
-Pinterest: https://www.pinterest.com/easymedicaldevice
-Instagram: https://www.instagram.com/easymedicaldevice
Did you had this blank in your head when an auditor asked you the validation documents of your software? I know your pain. So today we will try to help you validate your software with some automation. For that I have invited Christophe Girardey from Wega to help move on that direction
The post Why you should automate your Software validation? first appeared on Medical Device made Easy Podcast.
The post Why you should automate your Software validation? appeared first on Medical Device made Easy Podcast. hamza benafqir
We feel your pain when your bosses ask you to hire a QA RA person, but the challenge is that there is no Budget for it. But you want to impress them, so what to do. In this episode Mitch Robbins a professional recruiter is telling you what to do. But don’t think this will be easy.
The post Hire your QA RA person with no Budget first appeared on Medical Device made Easy Podcast.
The post Hire your QA RA person with no Budget appeared first on Medical Device made Easy Podcast. hamza benafqir
When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brainstorm and identify those risks. Usually, we follow ISO 14971 for that. But not all of your team is aware of this, and we are now short on time. So, what to do? Draft it by yourself or work with some colleagues. Naveen Agarwal will be sharing with us the best way to collaborate to create a successful Risk Management process. So, let’s listen to that.
Who is Naveen Agarwal?
Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:
Naveen Agarwal Linkedin : https://www.linkedin.com/in/naveenagarwal/
Linkedin Post: https://naveenagarwalphd.substack.com/p/collaboration-is-the-secret-sauce-for-riskmgmt
Achieve Website: https://www.achievexl.com
Let Us Talk Risk Newsletter: https://naveenagarwalphd.substack.com/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what are we talking about. This episode will help you understand AI and also understand what the risks to it are. This is really an interesting topic, but a lot of people are really afraid when we talk about AI. We will try to give you some tips to clarify the situation.
For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies who use Artificial Intelligence for their software.
Who is Christophe Girardey?
Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development.
Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:
Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/
Wega Website : https://www.wega-it.com/
Medical Device Compliance: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance
Data Sciences: https://www.wega-it.com/clinical-development-it#data-science
Wega Breakfast: Artificial Intelligence in GxP environments: https://www.youtube.com/watch?v=dCDwEkXd9jU&t=11s
Nature Article (co-authored):
https://www.nature.com/articles/s41582-020-00448-7FDA list of Software with AI: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices?
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
Have you ever been to an audit and the auditor is asking you to show them the validation of your Quality Management System software. The first reflex is to say “But I buy it like that so I don’t validate that” and the auditor to say “Ok, then there is a non-conformity to ISO 13485”. I know painful. So let’s review today the way to validate you Quality tools and why this seem so important. For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies to validate their software.
Who is Christophe Girardey?
Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Links from the Video
Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/
Wega Website : https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance https://www.wega-it.com/computer-systems-validation-quality-assurance
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
I am sure that at a certain point, your company will try to market your medical devices in Saudi Arabia. And now you are looking for the information that will help you to accelerate the registration of the products. In this episode, Ahmed Hendawy from Registitute will help us understand the best strategy to do that. He will explain to us also the similarities between SFDA and EU MDR. So if you are really motivated to register your product within SFDA then this is the right podcast episode for you.
Who is Ahmed Hendawy?
Ahmed is an esteemed leader in the field of healthcare consulting, renowned for his deep expertise in healthcare regulations, market access, and business strategy within the MENA region. As the founder and driving force behind Registitute, Ahmed has established the firm as a premier provider of specialized services in regulatory affairs and market access.
With a distinguished career, including a previous role as the Head of Regulatory Affairs for the MENA region, Ahmed has demonstrated exceptional skill in navigating complex regulations and spearheading successful market entry strategies. Under his visionary guidance, Registitute has garnered a reputation for excellence and innovation in the healthcare consulting landscape.
Registitute stands apart by delivering tailored solutions that address the unique challenges faced by healthcare organizations operating in the MENA region. Ahmed's strategic vision, combined with the expertise of the Registitute team, continues to drive positive change and support healthcare organizations in adapting to the ever-evolving healthcare landscape in the MENA region.
In summary, Ahmed's leadership and Registitute's unwavering commitment to providing exceptional services position them as a trusted partner for healthcare organizations seeking regulatory expertise and market access support in the MENA region.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:
Ahmed Hendawy Linkedin : https://www.linkedin.com/in/ahmed-hendawy-a0a81511a
Registitute LinkedIn: https://www.linkedin.com/company/registitute/
Registitute Website : www.registitute.com
AL TIRYAQ LinkedIn : https://www.linkedin.com/company/al-tiryaq/
SFDA website : www.sfda.gov.sa
SFDA Guidance for Medical Device registration: https://sfda.gov.sa/sites/default/files/2019-12/MDS-G5_1.pdf
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
july 2023regulatory update
The post Medical Device News – July 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
UK decided to add more time to implement the UKCA. Apparently, the EU amendment to extend the EU MDR and IVDR was also something they looked at to define their timeline. So, let’s see what will this mean for manufacturers with Alex Denoon, partner at the law firm Bristows.
The post What should you know on UKCA extension appeared first on Medical Device made Easy Podcast. hamza benafqir
Software development is really increasing in the Medical Device world and it is maybe important now to discuss about potential gaps that exist between the Software Development team and the Quality and Regulatory Affairs team. Dev team think that they have too much documents to create and quality thinks that the document that the dev team is creating is not really answering the requirements. So how to solve that.
Christophe Girardey from Wega who is dealing with that will tell us why we have this situation and also provide some hints on how this can be resolved.
Who is Christophe Girardey?
Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development.
Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:
Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/
Wega Website : https://www.wega-it.com/
Medical Device: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance
Agile : https://www.wega-it.com/computer-systems-validation-quality-assurance#agility-in-gxp
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Since March 2023 an extension for EU MDR and IVDR was voted by the EU Commission. This podcast episode will remind you the latest news and also answer some frequently asked questions from people. As you may see on the title there are some great misunderstandings, and the objective of today is to clear that out.
For that I have with me Florian Tolkmitt from Pro-Liance and we will try to give you the best content on EU MDR extension.
Who is Florian Tolkmitt?
Florian Tolkmitt is co-founder and CEO of PRO-LIANCE, a consultancy supporting medical device manufacturers with regulatory affairs, clinical affairs and quality management. PRO-LIANCE is based in Germany and serves customers. Florians favorite topics include clinical evaluation, post-market surveillance and risk management and he is also assistant professor at the University of Applied Sciences in Luebeck, Germany, where he teaches Clinical Evaluation to Master students. Apart from that he is the chair of the Regulatory Affairs Professionals Society Chapter in Germany and loves to network and bring the Regulatory Affairs and Quality Community closer together. Last but not least, Florian has a strong interest in Digitalization and is a founding member of the Medical Device Knowledge Unit initiative, that works on an open-source data model for Technical Documentation.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:
EU MDR extension: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf
Team NB Notified Body confirmation letter: https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-NB-ConfirmationLetterEU2023-607-20230503.docx
Florian Tolkmitt Linkedin : https://www.linkedin.com/in/floriantolkmitt/
Pro-Liance company Site: https://pro-liance.com/
EU 2023/607: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607 Podcast episode EU extension with Erik Vollebregt: https://podcast.easymedicaldevice.com/211-2/
LinkedIn Company: https://www.linkedin.com/company/pro-liance/
Social Media to follow:
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Sponsor MedBoard: www.medboard.com
EUROPE
Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf
EU MDR and IVDR consolidated versions
EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320
EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320
Confirmation letter:
EU Commission: https://health.ec.europa.eu/latest-updates/template-nb-confirmation-letter-framework-regulation-eu-2023607-2023-05-24_en
MDCG 2020-3 Significant changes: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en
Update Annex XVI timeline: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=PI_COM:Ares(2023)3232054
EMDN maintenance project launched: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6262
Spain: AEMPS and CNCps recognize the need to demonstrate to third parties the validity of expired certificates: https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-nuevo-procedimiento-del-cncps-para-confirmar-la-validez-de-los-certificados-emitidos-conforme-a-mdd/
Finland: RoHS is also applicable to Medical Devices: https://www.fimea.fi/web/en/-/rohs-act-also-concerns-medical-devices
Training:
Green Belt Certification Program June 26th until June 30th. https://school.easymedicaldevice.com/course/gb26
Switzerland
Incident reporting
Incident report for economic operators: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009e_WL%20Incident%20economic%20operators.pdf
Incident report for users: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_008d_wl-vorkommnismeldung-anwender.pdf.download.pdf/MU680_20_008e_WL%20incident%20report%20user.pdf
Designation of a Vigilance contact person for hospitals: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_10_007d_wl-vigilance-kontaktperson-medizinprodukte.pdf.download.pdf/MU680_10_007e_WL%20Vigilance%20contact%20person%20for%20medical%20devices.pdf
United Kingdom
New tutorial videos MHRA "How to register medical devices": https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
New Regulatory Pathway IDAP: https://www.gov.uk/government/news/new-regulatory-pathway-set-to-support-safe-patient-access-to-innovative-medical-technologies
Assistive Technology: https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use/assistive-technology-definition-and-safe-use
Report Adverse incidents for Software: https://www.gov.uk/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system/guidance-for-manufacturers-on-reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system
ROW
Australia: Guidance on applying the Advertising Code rules: https://www.tga.gov.au/how-we-regulate/advertising/how-advertise/advertising-guidance/resources/resource/guidance/guidance-applying-advertising-code-rules
Canada: Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-proposed-amendments-medical-devices-food-drug-regulations.html India: CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device : https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/
Egypt: European Parliament Decision of March 2023 regarding the transitional grace periods granted in relation to the application of MDR&IVDR rules and procedures: https://www.edaegypt.gov.eg/ar/%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2-%D8%A7%D9%84%D8%A7%D8%B9%D9%84%D8%A7%D9%85%D9%89/%D8%A7%D9%84%D8%A5%D8%B9%D9%84%D8%A7%D9%86%D8%A7%D8%AA/%D9%82%D8%B1%D8%A7%D8%B1-%D8%A7%D9%84%D8%A8%D8%B1%D9%84%D9%85%D8%A7%D9%86-%D8%A7%D9%84%D8%A3%D9%88%D8%B1%D9%88%D8%A8%D9%8A-%D8%A7%D9%84%D8%B5%D8%A7%D8%AF%D8%B1-%D9%81%D9%89-%D9%85%D8%A7%D8%B1%D8%B3-2023-%D8%A7%D9%84%D8%AE%D8%A7%D8%B5-%D8%A8%D8%A7%D9%84%D9%85%D9%87%D9%84-%D8%A7%D9%84%D8%A5%D9%86%D8%AA%D9%82%D8%A7%D9%84%D9%8A%D8%A9-%D8%A7%D9%84%D9%85%D9%85%D9%86%D9%88%D8%AD%D8%A9-%D8%A8%D8%AE%D8%B5%D9%88%D8%B5-%D8%AA%D8%B7%D8%A8%D9%8A%D9%82-%D9%82%D9%88%D8%A7%D8%B9%D8%AF-%D9%88%D8%A5%D8%AC%D8%B1%D8%A7%D8%A1%D8%A7%D8%AA-mdr-ivdr/
Saudi Arabia Webinar:
Explain The Essential Principles of Safety and Performance for Medical Devices: https://www.sfda.gov.sa/en/workshop/88451 Risk Management for Medical Devices: ISO 14971 Requirements https://www.sfda.gov.sa/en/workshop/88450
Podcast
Podcast 231: The truth about the UK vs EU situation with Claire Dyson: https://podcast.easymedicaldevice.com/231-2/
Podcast 232: Technical File inconsistencies identified by Notified Bodies with Adam Rae: https://podcast.easymedicaldevice.com/232-2/
Podcast 233: What if your Medical Device company goes bankrupt with Karandeep Badwal: https://podcast.easymedicaldevice.com/233-2/
Podcast 234: How to master Regulatory Intelligence with Ivan Perez Chamorro: https://podcast.easymedicaldevice.com/234-2/
Ask Easy Medical Device . We can help you
Contact at info@easymedicaldevice.com
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
We all need to keep ourselves up to date. But how to access reliable information and how often should a check be done. This is what we will discuss with Ivan Perez Chamorro from MedBoard. You will get some hints on how to optimize your search.
Regulatory intelligence seems to be a big scary word that people may think it needs a ton of experts to be able to master it. But with digitalization this needs less efforts now. When before you needed to check a lot of journals or visit a lot of country websites, now there are tools that helps you do it quicker. This is mainly the topic of our discussion with Ivan Perez Chamorro from MedBoard.
Who is Ivan Perez Chamorro? Ivan Perez Chamorro is CEO and Founder of MedBoard, a technology company that organises medical technology information and data, makes it fast accessible to manufacturers and key stakeholders, and it is integrated with breakthrough tools as the Vigilance automation. MedBoard is made up of leading engineers, scientist and medical professionals. This big data platform covers from Regulatory, to Clinical, Market and Technical. Ivan has both strong science and business background, he holds a degree and MSc in Physics from Universidad de Salamanca, and an MBA from IE Business School. Ivan is very active in medical device industry, and he is also part of the TOPRA MedTech SPIN. After having a chronic sports injury while playing basketball, and spending many years in rehabilitation, he decided after physics graduation to work in the medical devices industry. Ivan has lived in different countries and likes travelling, painting, and adventure sports, and has special interest in innovation, entrepreneurship, and technology. MedBoard is not the first project, and Ivan has have a number of entrepreneurship projects in the past, in the medical and outside of medical devices industry. Before Medboard, Ivan had worked for many years within the industry, as an employee of leading medical companies and as a consultant in the areas of product and business development, regulations, and strategy, from operational roles to advising technical and top management. He has broad experience with different types and classes of medical devices and combination products, supporting a variety of organization models, from start-ups to large corporations.
Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link: * Ivan Perez Chamorro LinkedIn: https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22/ * Blog post Medboard:
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to master regulatory intelligence appeared first on Medical Device made Easy Podcast. hamza benafqir
This is really a difficult situation if your company goes bankrupt. But now the idea is what to do regarding the products that are still on the market. You still have some responsibility and the EU MDR is asking you to put in place some process to anticipate that. This is what we will discuss with Karandeep Badwal today. We’ll try to give you some advice on how to overcome this situation.
Who is Karandeep Badwal?Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video * Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/ * Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal * The Medtech Podcat: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3 * QRA Medical Youtube video: https://www.youtube.com/channel/UC1ygqJO7_HV30XVdHyN-0lg
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What if your Medical Device Company goes Bankrupt? appeared first on Medical Device made Easy Podcast. hamza benafqir
This week with Adam Rae we will talk about the Technical Files inconsistency that we noticed while working on some projects. Adam will provide his list of issues like Intended purpose, Clinical Evaluation… So if you want to avoid these issues don’t miss this episode as they can cost you time and money.
Who is Adam Isaacs Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working in aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links* LinkedIn profile Adam Isaacs Rae: https://www.linkedin.com/in/adam-isaacs-rae/ * Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/
Social Media to follow* Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedical… * Instagram: https://www.instagram.com/easymedical…
The post Technical Files Inconsistencies Identified by Notified Bodies appeared first on Medical Device made Easy Podcast. hamza benafqir
Since Brexit, the UK market is really trying to find a way to come back to normal and extract themselve from the EU legislation. They are doing it step by step but for the moment a lot of the products we see are relying on the EU rules. But UKCA is about to be the rule. I mean we thought this will be the rule but apparently there are new timelines coming.
So let’S discuss that with Claire Dyson
Who is Claire Dyson?
Claire Dyson is a seasoned professional in the Med Tech space having spent more than a decade in manufacturing and the last 5 years in certification bodies. She began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and became Head of UK Approved Body for DEKRA in 2022. She recently resigned and is spending some time creating accessible content to support manufacturers with the regulatory transitions being implemented across Europe. Claire has set up her own company, CAPD Consultancy Ltd, whilst building up a network to help identify the needs across the industry and provide the right type of help that manufacturers need.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:
Claire Dyson Linkedin page: https://www.linkedin.com/in/claire-dyson-85845b4b/
UK transition timelines: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
UK transition rule: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
UK medical device regulation: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
UK Government’s response to the 2021 consultation outlining the future of UK medical device regulations: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1085333/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_theUnited_Kingdom.pdf
Social Media to follow:
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldeviceAuthorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
•Team-NB Sector Survey 2022 :https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-MD-Sector-Survey-PressRelease-20230411.pdf
• MDCG planning available :https://health.ec.europa.eu/system/files/2023-04/md_events_2023_en_1.pdf •TEAM-NB position paper : https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419.pdf
•Finland - Electronic Submission for Medical Devices :https://www.fimea.fi/web/en/-/electronic-submissions-for-medical-devices-will-be-opened-on-2-may-2023
•France- Digital Medical Application reimbursement :https://esante.gouv.fr/espace-presse/lancement-de-la-prise-en-charge-anticipee-des-dispositifs-medicaux-numeriques
• Switzerland - IVD performance studies : https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf
•Switzerland – IMDRF OFFICIAL OBSERVER :https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/swissmedic-official-observer-imdrf.html
• UK - Transition from CE to UKCA :https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
• Training EU MDR :https://school.easymedicaldevice.com/course/gb25
USA: Draft guidance on PCCP for AI/ML :https://www.fda.gov/media/166704/download o USA: Radiation Sterilization Master File Pilot Program :https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-radiation-sterilization-master-file-pilot-program.
o Australia: Regulation for software based medical devices :https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices
o China: Guideline for Medical Device :https://www.cmde.org.cn/xwdt/zxyw/20230404163902154.html o India: List of Notified Bodies registered in India :
o Mexico, Colombia & Cuba sign the Acapulco Declaration : https://www.gob.mx/cofepris/articulos/se-firma-declaracion-de-acapulco-para-creacion-de-la-agencia-reguladora-de-medicamentos-y-dispositivos-medicos-de-latinoamerica-y-el-caribe?idiom=es oSaudi Arabia Webinars :
•May 9, 2023 Guidance on Medical Devices Classification https://www.sfda.gov.sa/en/workshop/88229
•May 22, 2023 Product Sterilization Requirements for Medical Devices https://www.sfda.gov.sa/en/workshop/88228
oPodcast Nostalgia
•Episode 227: What is a SOUP for your Software Development Christian Kaestner Medical Device HQ https://podcast.easymedicaldevice.com/227-2/
•Episode 228: Prepare your Audit like a PRO with Karandeep Badwal https://podcast.easymedicaldevice.com/228-2/
•Episode 229: Transition to Agile for Software as Medical Device: https://podcast.easymedicaldevice.com/229-2/
Ask Easy Medical Device . We can help you
•Contact at info@easymedicaldevice.com
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
We start to talk more and more of Software as Medical Device or SaMD. This time we will check with you how to develop a Software and transition to the Agile methodology with the company IronRooster.
Waterfall? Agile? … The methodology to develop a Software are multiple but you need as a company to define it prior to the project so you have the right pathway to follow. And in this episode of the podcast we will help you transition to the AGILE methodology for Software development. This is a well known method but we’ll try also to explain its advantages and also look at the way for you to transition to it. Bence and Attila from IronRooster will be my guests and they will tell you the tips an tricks about Agile development
Who is Bence Török? I am Bence, a proud member of the Iron Rooster team for two years now, spending most of my time trying to improve a MedTech project. I began my journey in the IT field as a technical writer working on Telecommunication projects, but after joining Iron Rooster, I quickly realized that project management was where I wanted to focus. Therefore, I delved into it and continue to expand my knowledge each day. Currently, I manage several MedTech projects and work with excellent software professionals in the blood banking industry, where we cover everything from donor recruiting to laboratory testing.
Who is Attila Katona? My name is Attila, and I am a senior member of the Iron Rooster team. I have been a long-time (tor)mentor for my merry team of quality assurance and regulatory compliance experts in our medical software development company. Over the years, I have been involved in 50+ projects in half a dozen different roles, performing various roles ranging from requirements engineering and test management to designing complex product documentation processes and full QMS maintenance.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video * IronRooster Linkedin page: https://www.linkedin.com/company/ironrooster/ * Bence Linkedin Page: * Attila Linkedin Page: * IronRooster website: https://ironrooster.io/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Transition to Agile for Software as Medical Device appeared first on Medical Device made Easy Podcast. hamza benafqir
If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you should be prepared for that with Karandeep Badwal.
An Audit is really an exercise that all Quality and Regulatory people should understand to master it. See it as a performance on stage, or a sport competition. Before it happens, you should prepare yourself. We will discuss on this episode with Karandeep Badwal of the way that you should be preparing and the tips and tricks that you will need to know. Internal audit, CE audi, ISO audit, MDSAP audit, Supplier audit … You’ll have to go through this within many occasions so be ready for it.
Who is Karandeep Badwal?
Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video
Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/
Easy Medical Device blog on audit: https://easymedicaldevice.com/internal-audit/
Podcast episode on audit: https://podcast.easymedicaldevice.com/175/
Video on internal audit: https://www.youtube.com/watch?v=UA_J_WXLPag&pp=ygUiZWFzeSBtZWRpY2FsIGRldmljZSBpbnRlcm5hbCBhdWRpdA%3D%3D
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
In this context SOUP is not a dish but Software Of Unknown Provenance which is the term used for Software that was not created by you. Christian Kaestner from Medical Device HQ will explain to us what you should consider when you have a SOUP within your product.
SOUP is the acronym for Software Of Unknown Provenance. This is mainly a piece of software that you want to use on your Medical Device but that you have not developed yourself. So if you have such a thing, then you need to listen to this podcast episode with Christian Kaestner from Medical Device HQ.
Who is Christian Kaestner? Christian Kaestner is a highly skilled professional with over 25 years of experience in the medical device field. As a software developer with a deep interest in medical device software, Christian has the technical background to understand software development. Christian was on the project teams that authored IEC 62304 and IEC 82304-1, so he has in-depth experience working with standards. If you’re looking to improve your team’s knowledge and skills, Christian offers online courses through Medical Device HQ to keep you up-to-date with industry best practices. He can also guide you in setting up your development process to comply with relevant standards. Visit medicaldevicehq.com to learn more, and feel free to connect on LinkedIn.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video* LinkedIn: https://www.linkedin.com/in/christiankaestner/ * I’m happy to answer short follow-up questions through LinkedIn messages. Blog post on how to manage SOUPs: https://medicaldevicehq.com/articles/managing-and-documenting-soup-and-ots-in-medical-device-software/ Medical device resources on YouTube: https://www.youtube.com/medicaldeviceHQ * Playlist with medical device software videos on YouTube: https://www.youtube.com/playlist?list=PLHbDOHytLFxGSmU8aiSWXskPN0qZv0VPg Link to SaMD course: https://medicaldevicehq.com/samd
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post What is a SOUP for your Software Development? appeared first on Medical Device made Easy Podcast. hamza benafqir
Today on this Medical Device news for March 2023 we’ll talk about
• The EU MDR Extension vote https: //health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a.pdf
• The Notified Bodies that are certified https: //www.team-nb.org/frequency-of-complete-re-assessments-of-notified-bodies/
• The changes in EU spain, UK, Switzerland, Belgium https: //www.sfda.gov.sa/sites/default/files/2023-03/MDS-G012A.pdf
• But also Middle East, USA, Brazil. https: //www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/consumidor-ganha-plataforma-para-notificacao-de-eventos-adversos
► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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► Links from the Video – https://www.medboard.com/
– Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
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► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice
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The post Medical Device news for March 2023 appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book “Safety Risk Management for Medical Devices”.
If you have to perform risk management for a software as a Medical Device or Medical Device software you may think how this can be done?, Are the tools, standards, the same as for normal medical devices? Are the risks different? Bijan Elahi will be my guest on this episode and will explain to us the best practices for SaMD risk management. Don’t miss this and also his book called “Safety Risk Management for Medical Devices”. Link below.
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Who is Bijan Elahi?Bijan Elahi has worked in safety risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. He started his work in risk management in aerospace; last working on the Space Shuttle at NASA before transitioning to the medical device industry in the early 1990’s.
Bijan is the corporate expert on risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Delft University of Technology, and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the book Safety Risk Management for Medical Devices.
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Who is Monir El Azzouzi?Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
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Link:– Bijan Elahi LinkedIn Profile
– Book: “Safety Risk Management for Medical Devices”:
– Episode 207: Why Risk Management is important to Medical Device development:
– Episode 216: How to evaluate Benefit-Risk ratio for Medical Devices?
– Authorized Representative and Importer services:
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► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice
—————————————————————————————— #easymedicaldevice #medicaldevice #regulatorycompliance
The post How to perform Risk Management for a Software ? appeared first on Medical Device made Easy Podcast. hamza benafqir
The EU MDR is requiring more transparency and the PMS has a lot to play in it. In this episode, we will explain to you a difference that is visible for PMS which is Proactive Postmarketing Surveillance. We will explain what they mean by that and how some digital tools can help you.
Who is Marcus Emne? Marcus Emne is the CEO & founder of Hoodin, the intelligence SaaS for life science & compliance. Marcus has extensive experience in international business from both high tech, software and life sciences. Over the last years, he has had a focus on intelligence and the subdomains Ai, Automation and Machine Learning in relation to regulatory needs within life science. If you wish to get further guidance or discuss RA/QA in relation to Ai, Automations and Machine Learning, feel free to contact Marcus.
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Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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Links from the Video* Schedule a discovery call: https://rb.gy/nl9ghd * email: marcus@hoodin.com * LinkedIn: https://www.linkedin.com/in/marcusemne/ * LinkedIn profile Marcus Emne: https://www.linkedin.com/in/marcusemne/ * Hoodin web page: https://www.hoodin.com/ * Schedule a discovery call: https://rb.gy/nl9ghd * MDCG PMS 2022-21 https://health.ec.europa.eu/system/files/2023-01/mdcg_2022-21_en.pdf * Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/
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► Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post How to create a Proactive Postmarketing Surveillance? [EU MDR] appeared first on Medical Device made Easy Podcast. hamza benafqir
Vigilance Reporting is a process that you should have but that you don’t want to us. In fact not having any vigilance reporting is a sign that you product is doing well. But having one means that maybe you need to improve your device.
So on this episode we will explain to you what is Vigilance Reporting and how you should build it. We will explain EU reporting, UK, but also other regions. We will also mention about IMDRF guidances that are important.
► Who is Adam Isaacs Rar?
Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.
► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links:
LinkedIn profile Adam Isaacs Rae: https://www.linkedin.com/in/adam-isaacs-rae/
Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/
► Social Media to follow
■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedical...
■ Instagram: https://www.instagram.com/easymedical...
medtech #medicaldevice #compliance
Here is your Regulatory Update for the month of March 2023. Check all the links below
- EU MDR 2017/745 extension has been voted: https://www.raps.org/news-and-articles/news-articles/2023/2/europeanparliament-votes-to-extend-mdr-transition
-UK Impact of extension of Medical Device Regulations transitional period and the validity of Certificated in the EU: https://www.gov.uk/government/news/impact-of-extension-of-medical-device-regulations-transitional-period-and-thevalidity-of-certificates-in-the-eu
-Ireland - Article 97 request form : https://www.hpra.ie/homepage/about-us/publications-forms/forms-applications/item id=e4cb1326-9782-6eee-9b55-ff00008c97d0
-EU Team-NB. Best practice Guidance for the submission of Technical Documentation for IVDR: https://www.teamnb.org/team-nb-pp-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii-and-iii-of-in-vitrodiagnostic-medical-devices-regulation/
-EU Team-NB . IVDR technical Documentation training for manufacturers: Wednesday June 14th, 2023 https://www.teamnb.org/wp-content/uploads/members/M2023/Leaflet-IVD-TC-Manufacturers-Training-
-EMA pilots scientific advice for certain High-Risk Medical Devices: https://www.ema.europa.eu/en/news/ema-pilotsscientific-advice-certain-high-risk-medical-devices
- New Notified Bodies ○ NSAI for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321463&version_no=10
○ MDC for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321397&version_no=8
-Spain AEMPS: Notice addressed to Notified Bodies and Manufacturers of Nasal Sprays with Virucidal or Microbicidal action: https://www.aemps.gob.es/informa/la-aemps-publica-una-nota-de-aviso-dirigida-a-organismos-notificados-y-a-fabricantesde-esprais-nasales-con-accion-viricida-o-microbicida/
-Swiss - Q&A for IVD notification: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_010d_mb_faq_invitro_diagnostika_meldungen.pdf.download.pdf/BW630_30_010e_MB_FAQ_Notifikationen_IVD.pdf
/search-fdaguidance-documents/guidance-industry-and-food-and-drug-administration-staff-assemblers-guide-diagnostic-xray-equipment
-Performance standard for Diagnostic X-Ray systems. https://www.fda.gov/regulatory-information/search-fdaguidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-majorcomponents-21cfr-102030-102031-102032
-Medical X-ray imaging devices coformance with IEC Standards: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-x-ray-imaging-devices-conformance-iec-standards
-List of cleared Companion Diagnostic: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-orapproved-companion-diagnostic-devices-in-vitro-and-imaging-tools
-US Medsun February 2023: https://www.fda.gov/media/165125/download
-SAUDI-DI Webinar March 20th 2023 https://www.sfda.gov.sa/en/workshop/87814
-Link to Webex: https://zoom.us/j/95729656046?pwd=NmNOLzZYT0hmK3JqVXhPQ25LQmQ5Zz09 -Link to Webex: https://zoom.us/j/93572022832?pwd=K1ZVL2xTNXFHV3NEdXVGbk4yN0Z3Zz09
-South Africa. SAPHRA Q&A on Licensing of Medical Device establishment: https://www.sahpra.org.za/wpcontent/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device- Establishments.pdf
○ Episode 219 - Biological Evaluation: Top Big Mistakes (Paul Fernandes and Laura Fouzari) https://podcast.easymedicaldevice.com/219-2/
○ Episode 220 - SaMD International Reach (Stephane Berger) https://podcast.easymedicaldevice.com/220-2/
○ Episode 221 - Prepare your transition from Class I to Class Ir https://podcast.easymedicaldevice.com/221-2/
○ LinkedIn Live - Samd Class I - To be published this week
► Social Media to follow
■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice
easymedicaldevice #medicaldevice #regulatorycompliance
The EU MDR is planning to be really challenging for Class I reusable Surgical Instruments as they will need to move to Class Ir. In this Episode, Tautvydas from Test Labs will explain to us what is expected from Medical Device Manufacturers. What they should prepare for being compliant with the new regulation?
Who is Tautvydas Karitonas? Tautvydas is focused on accelerating access to the market for medical devices. He has almost a decade of experience developing state-of-the-art products for healthcare, which are now used in hospitals worldwide. Tautvydas provides expertise in product development, validation, and problem-solving.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video * LinkedIn profile Tautvydas: https://www.linkedin.com/in/tautvydaskaritonas/ * Test Labs webpage: www.testlabsuk.com * MDCG 2020-2 – Class I transition: https://health.ec.europa.eu/document/download/e87d08dc-87ab-49d9-8ffa-5552fa978d14_en * Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/
Social Media to follow * Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi * Twitter: https://twitter.com/elazzouzim * Pinterest: https://www.pinterest.com/easymedicaldevice * Instagram: https://www.instagram.com/easymedicaldevice
The post Prepare your transition from Class I to Class Ir appeared first on Medical Device made Easy Podcast. hamza benafqir
We are in a global world, so normally what is good for the EU can be also good for other countries. But here the only barrier is local law. This is mainly what we will discuss on this Podcast. We will use the example of SaMD or Software as a Medical device for it and share with you the experience that we have but this is applicable to nearly all medical devices. Check the podcast page at: https://podcast.easymedicaldevice.com/220-2/
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► Who is Stéphane Berger?
Holder of a diploma in Electronics, with an experience of 25 years in the industry, after 10 years in the semiconductor field service business, he entered the medical device world in an ultrasound imaging company and started to implement ISO13485 requirements as customer service director and operation director. He began his career in quality and regulatory affairs in a recognized Notified Body with a position of auditor specialized in medical devices and software. He is currently holding the position of Regulatory and Quality Affairs Manager at Avicenna.AI, a French start-up that provides artificial intelligence solutions for radiology. Their products are registered in more than 40 countries worldwide and follow the evolving world of regulation around the Artificial Intelligence and Medical Device markets.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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► Links from the Video
■ LinkedIn Profile of Stéphane Berger: https://www.linkedin.com/in/bergerstephane ■ Avicenna Website: https://avicenna.ai/
■ WHO listing of Worldwide requirements: https://apps.who.int/iris/rest/bitstreams/1480622/retrieve
■ Authorized Representative Service: https://easymedicaldevice.com/authorised-representative-and-importer/
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► Social Media to follow
■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice
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easymedicaldevice #medicaldevice #regulatorycompliance
In this podcast episode, Laura and Paul will share with us the big mistakes done by some Medical Device manufacturers when they are considering Biological Evaluation for their products.
You may need to take some notes as Laura and Paul are really knowledgeable on this process as they are onboarding some of their customers at ICARE Group and they will share with us the good, Bad, and ugly.
Don’t forget also to check their webpage to see what Icare can provide to you as a service.
Who is Paul Fernandez? Holder of a Master’s degree in Toxicology and after a brief training in nutrition research, he began his career in regulatory affairs specializing in medical devices at ICARE when the MDR came into force. Curious by nature, and specialized in biocompatibility testing and in biological/toxicological risk analysis, he accompanies and guides many MD manufacturers in their biological evaluation strategy and after audit with authorities. He is currently a referent for the biological and toxicological safety of MD within Groupe ICARE.
Who is Laura Fouzari? Following a master degree in toxicokinetics and toxicology, LF has specialized in the medical device sector and has started working on these themes for 4 years. Nowadays, she is working as a safety and toxicological safety assessor in the Regulatory Affairs Unit within the Biotox Unit of Groupe Icare.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links: * Icare Group: https://www.groupeicare.com/ * LinkedIn Paul Fernandez: https://www.linkedin.com/in/fernandesp * LinkedIn Laura Fouzari: https://www.linkedin.com/in/laura-f-712865150/ * FDA document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and * Webicare subscription: https://www.groupeicare.com/events/webicare-etude-alternative-focus-chimie/
The post Biological Evaluation: Top Big mistakes appeared first on Medical Device made Easy Podcast. hamza benafqir
Here is your Regulatory Update for the month of February 2023. Check all the links below
| – EU amendment of the EU MDR and IVDR: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en – Proposal for extension consultation: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period-extension_en – Q&A: https://ec.europa.eu/commission/presscorner/detail/en/QANDA_23_24 – General Secretariat: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_5585_2023_INIT – Vote: https://eur-lex.europa.eu/procedure/EN/2023_5?qid=1675093438485&rid=1 |
| – EU Coverage of MDR code: https://health.ec.europa.eu/latest-updates/update-coverage-designation-codes-mdrivdr-notified-bodies-january-2023-2023-01-13_en |
| – EU list of Standard Fees for Notified Bodies: https://health.ec.europa.eu/latest-updates/mdcg-2023-2-list-standard-fees-january-2023-2023-01-12_en |
| – EU Delegated directive for exemption for lead as a thermal stabilizer in Polyvinyl Chloride used as base material in sensors used in in-vitro diagnostic medical devices: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13594-Electrical-equipment-lead-in-polyvinyl-chloride-for-sensors-used-in-diagnostic-medical-devices-RoHS-exemption-_en |
| – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of EU MDR and IVDR: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf |
| – Annual overview of devices subject to the clinical Evaluation Consultation Procedure (CECP): https://health.ec.europa.eu/latest-updates/annual-overview-devices-subject-clinical-evaluation-consultation-procedure-cecp-april-2021-june-2022-2023-01-23_en |
| – Training EU MDR 2017/745: https://school.easymedicaldevice.com/course/gb24 |
| – UK government response to the consultation on Medical Device Regulation: https://www.gov.uk/government/publications/government-response-to-the-rhc-report-on-medical-devices |
| – UK MHRA increases UK assessment capacity for In-Vitro diagnostic devices: https://www.gov.uk/government/news/mhra-increases-uk-assessment-capacity-for-in-vitro-diagnostic-devices |
| – Swiss – FAQ on Medical Devices: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009e_MB_FAQ_Notifications.pdf |
| – Notified Bodies SLG Prüf und Zertifisierungs – 37 – EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=321000&version_no=11 https://www.slg.de.com/home.html EU MDR 37: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 IVDR 8: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 |
| – Saudi Arabia: Guidance AI/ML Software based: https://www.sfda.gov.sa/sites/default/files/2023-01/MDS-G010ML.pdf |
| – Leading Voices in Medtech: https://lnkd.in/eUJcAQxE https://www.linkedin.com/posts/melazzouzi_medtech-easymedicaldevice-medicaldevices-activity-7025727213714997248-plJX?utm_source=share&utm_medium=member_desktop |
Podcast episodes:
How to improve the relationship between QA – RA and Marketing?
Breaking News: EU MDR Extension Proposal is out for consultation
How to evaluate Benefit-Risk Ratio for Medical Devices?
How to do Post-Marketing Surveillance in the US (vs EU)?
The post Medical Device News: February 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
We talk a lot about Post Marketing Surveillance in Europe with EU MDR, MDCG, and all the rules to follow. But when you hear about how this is done in the US you will see that this is really completely different.
For that, I have invited Robert Packard to help us understand the rules behind it and also talk about an IT application that can help you to gather data for your PMS. Let’s review that together.
Who is Robert Packard? I have 20 years of experience in the medical device industry and another 10 years of experience in biotech manufacturing validation and scale-up. I am a UConn graduate in Chemical Engineering. I was Director of Quality and Regulatory Affairs at four different medical device start-ups, and I was President/CEO of a laparoscopic imaging company I co-founded in 2004. My quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009-2012, I was a lead auditor and instructor for BSI – one of the largest Notified Bodies for CE Marking and MDSAP Certification.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video * 522 Post-Market Surveillance Studies Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm * Post-Approval Studies (PAS) Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm * Post Market Management of Cybersecurity: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices * MAUDE Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM * Basil Systems PMS Database Tool: https://basilsystems.com/easy-medical-device/ * Webinar on PMS EU and US: https://medicaldeviceacademy.com/post-market-surveillance-webinar/
The post How to do Post-Marketing Surveillance in the US (vs EU)? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The evaluation of the Risk-Benefit ratio is key for Risk Management Files per ISO 14971 or when you build your Clinical Evaluation Report or when you need to define the risk of using a particular technology against another. I mean that risk-benefit evaluation is mainly what helps us to decide that our product is safe and performant.
So on this episode, Naveen Agarwal from Achieve will be my guest and help us understand the best way to measure your benefit-risk ratio.
Who is Naveen Agarwal?Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links:* Naveen LinkedIn profile: https://www.linkedin.com/in/naveenagarwal * Exceed consulting solution: www.exeedqm.com * Achieve training: www.achievexl.com
The post How to evaluate Benefit-Risk Ratio for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Finally, a proposal is now available, and we wanted to discuss it and identify if there are any surprises. Erik Vollebregt from Axon Lawyer is helping us understand all this.
This proposal is also under consultation until January 18th, 2023. So don’t miss that as this is tomorrow for those seeing the episode today.
To conclude, this is only a proposal, so this is not approved. We are still waiting for the vote. Without this vote nothing is real.
Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and the protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical device-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video * Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt * Axon Lawyers: https://www.axonlawyers.com/ * Book EU MDR: https://medicaldeviceslegal.com/2022/10/27/the-2nd-edition-of-the-enriched-mdr-and-ivdr-is-available-now/ [COUPON CODE: easymedicaldevice10] * Download Decision Tree: https://podcast.easymedicaldevice.com/wp-content/uploads/2023/01/MDR-amendment-flowchart2.pdf * EPSCO Meeting article: https://medicaldeviceslegal.com/2022/12/11/the-epsco-meeting-and-beyond/ * Consultation link: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Extension-of-the-transition-period-for-medical-devices_en * Commission proposal: https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf
The post Breaking News: EU MDR Extension Proposal is out for consultation appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In the Medical Device world, you need to work as a team. Sometimes it is really difficult and we will discuss that with Omar M. Khateeb. The relationship between Marketing and QA RA is one of those examples. One is willing to sell creatively and the other is trying to avoid any legal issues. So how should this be balanced? Don’t miss this episode to learn more about how you should interact with other team members within your industry.
Who is Omar M. Khateeb? Omar is a MedTech marketing and sales professional who founded Khateeb & Co which helps MedTech companies grow their sales pipeline and drive product adoption at scale using social media. Having spent over a decade in disruptive technology ranging from robotics and AI to software, Omar uses his skills around persuasion, technology adoption, and category design to help companies get traction in the market.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links * Free Webinar on Using Digital in Medical Sales: https://www.khateebandco.co/ht-1 * Follow Omar M. Khateeb on LinkedIn https://www.linkedin.com/in/okhateeb/ * Instagram https://www.instagram.com/omar.m.khateeb/ * Twitter https://twitter.com/OmarMKhateeb * TikTok: https://www.tiktok.com/@omar.m.khateeb * Facebook https://www.facebook.com/OmarMKhateeb/ * Check Out The State of MedTech on YouTube https://youtube.com/@thestateofmedtech * Apple: https://podcasts.apple.com/om/podcast/state-of-medtech/id1597688404 * Spotify https://open.spotify.com/show/5NVrQLfLk0EXDeKDdX7BB6?si=447b569ad6134abb * Google: https://podcasts.google.com/feed/aHR0cHM6Ly9hbmNob3IuZm0vcy83MjRjZWI1MC9wb2RjYXN0L3Jzcw?sa=X&ved=0CAMQ4aUDahcKEwjIgYbpttr1AhUAAAAAHQAAAAAQAQ&hl=en
The post How to improve the relationship between QA – RA and Marketing? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
- EU MDR extension
- Implementation of the Medical Device Regulation https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf
- Provisional Agenda 9th Meeting – Implementation of the Medical Device Regulation (MDR) https://data.consilium.europa.eu/doc/document/ST-15453-2022-INIT/en/pdf
- Implementation of the Medical Device Regulation (MDR): EU MDR Transition Period extension proposal by the European Commission. https://video.consilium.europa.eu/event/en/26353
- Erik Vollebregt Article: https://medicaldeviceslegal.com/2023/01/01/mdr-and-ivdr-outlook-for-2023/
- Implementing rolling plan
- Implementation Rolling Plan: Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Latest update: November 2022 https://health.ec.europa.eu/system/files/2022-12/md_rolling-plan_en.pdf
- Borderline manual
- Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 – Version2 – December 2022 https://health.ec.europa.eu/latest-updates/manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-version2-december-2022-2022-12-15_en
- Team NB
- AI act for Notified Bodies – Team-NB Position Paper – The designation of notified bodies under the upcoming Artificial Intelligence Act https://www.team-nb.org/wp-content/uploads/members/M2022/Team-NB%20PositionPaper-AI%20Designation-V1-20221216.pdf
- Notified Bodies appointed
- QMD Services GmbH (NB 2962), 8th Notified Body designated under IVDR (EU) 2017/746 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320456&version_no=1
- ICIM S.P.A., 36th Notified Body designated under MDR (EU) 2017/745 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320256&version_no=12 11:31
- UK Approved bodies
- UK Approved bodies. https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices
- Training to attend and Books to read
- Green Belt 24th Edition : https://school.easymedicaldevice.com/course/gb24/
- EUDAMED Simplified 28th February 2023: https://eudamed.com/index.php/eudamed-training/
- PRRC Training 28 Feb 2023: https://boumansconsulting.com/prrc-academy-cat/2023-02-28-03-07-in-house-manufacturer-prrc-starter-training/
- Erik Vollebregt Book – easymedicaldevice10 https://medicaldeviceslegal.com/2022/10/27/the-2nd-edition-of-the-enriched-mdr-and-ivdr-is-available-now/
- MDCG 2022-17
- MDCG position paper on ‘hybrid audits’ – December 2022 https://health.ec.europa.eu/latest-updates/mdcg-2022-17-mdcg-position-paper-hybrid-audits-december-2022-2022-12-06_en
- MDCG 2022-18
- MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate https://health.ec.europa.eu/latest-updates/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en
- MDCG 2022-19 and 20
- Performance study application/notification documents under Regulation (EU) 2017/746 https://health.ec.europa.eu/latest-updates/mdcg-2022-19-performance-study-applicationnotification-documents-under-regulation-eu-2017746-2022-12-12_en
- Substantial modification of performance study under Regulation (EU) 2017/746 https://health.ec.europa.eu/latest-updates/mdcg-2022-20-substantial-modification-performance-study-under-regulation-eu-2017746-december-2022-2022-12-14_en
- MDCG 2022-21
- Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 https://health.ec.europa.eu/latest-updates/mdcg-2022-21-guidance-periodic-safety-update-report-psur-according-regulation-eu-2017745-december-2022-12-16_en
- Switzerland Annex XVI products
- Frequently Asked Questions on medical devices – FAQ MD: Update of the section “Products without medical purpose” https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices/faq.html
- US Product Codes
- Non-Invasive Body Contouring Technologies https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies
- Augmented Reality and Virtual Reality in Medical Devices https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices
- SFDA Classification
- Guidelines for classification of medical devices and supplies https://www.sfda.gov.sa/sites/default/files/2022-12/MDS%E2%80%93G008.pdf
- PODCAST nostalgia
- Team-PRRC panel discussion https://podcast.easymedicaldevice.com/210-2/
- Is EU MDR extended? https://podcast.easymedicaldevice.com/211-2/
- Grow your LinkedIn Profile: https://podcast.easymedicaldevice.com/212-2/
The post Medical Device News: January 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Getting some visibility is the key to growing your LinkedIn Profile. And on this episode, we tell you how to be more visible or help build a community. As always you cannot do that alone so we propose you a challenge at the end.
Who is Karandeep Badwal?
Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- LinkedIn Karandeep Profile: https://www.linkedin.com/in/karandeepbadwal/
- Hashtag EMDchallenge: https://www.linkedin.com/feed/hashtag/?keywords=%23EMDchallenge
On December 9th, 2022, the EU Commission made a proposal to extend the transition period of the EU MDR 2017/745. But some people think this is already done which is not the case.
There was also at the exact moment the publication of the MDCG 2022-18 on Article 97 used to continue placing devices on the market. To clarify all that I have invited Erik Vollebregt from Axon Lawyers to help us understand the situation.
Many things were said, so let’s now debunk all the rumors and provide you with some clear understanding.
Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and the protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video * Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt * Axon Lawyers: https://www.axonlawyers.com/ * Book EU MDR: https://medicaldeviceslegal.com/2022/10/27/the-2nd-edition-of-the-enriched-mdr-and-ivdr-is-available-now/ [COUPON CODE: easymedicaldevice10] * EPSCO Meeting article: https://medicaldeviceslegal.com/2022/12/11/the-epsco-meeting-and-beyond/ * Commission briefing note on EPSCO meeting: https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf * MDCG 2022-18: https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-18_en.pdf * Easy Medical Device Authorized Representative: https://easymedicaldevice.com/authorised-representative-and-importer/
The post Is EU MDR extended? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Imagine that you have a question to ask the EU Commission, your Notified Body, or any association about being a PRRC. Then this is the episode to listen to. During the Team-PRRC event on November 3 and 4 2022, I was able to record some of the sessions and propose them to you know. Here are the people that were on the panel:
- Bassil Akra, Board Member of Team-PRRC association as the facilitator https://www.linkedin.com/in/bassil-akra-2388b84b/
- Mario Gabrielli Cossellu – EU Commission https://www.linkedin.com/in/mariogabriellicossellu/
- Orla Daly – EU Commission https://www.linkedin.com/in/orla-daly-354128b4/
- Francoise Schlemmer – Team-NB https://www.linkedin.com/in/francoise-schlemmer-baa16011/
- Christopher Kipp – BVMed https://www.linkedin.com/in/christopher-kipp-b16ba71b1/
And here are the questions answered:
- Why a PRRC is needed
- Will Notified Bodies issue an NC when manufacturers have no PRRC when they are following the MDD directive?
- What does it mean to ensure compliance for a PRRC?
- What notified bodies are expecting from PRRC to ensure compliance
- Is it the intention of the regulation to put PRRC in Jail?
- Can a CEO be a PRRC for its company?
- Lake of resources to help manufacturers?
- PRRC Training?
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Link* Team-PRRC association: https://www.team-prrc.eu/ * EU Authorized Representative: https://easymedicaldevice.com/eu-rep/ * UK responsible person: https://easymedicaldevice.com/uk-responsible-person/ * Swiss representative: https://easymedicaldevice.com/swiss-authorised-representative/
The post MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
HOT TOPICS
Europe
Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
- https://webgate.ec.europa.eu/regdel/#/implementingActs/7377?lang=en
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2346
Reclassification of groups of certain active products without an intended medical purpose
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32022R2347
Updated information pack for candidate EU reference laboratories published
- https://health.ec.europa.eu/latest-updates/updated-information-pack-candidate-eu-reference-laboratories-published-2022-11-30_en
51th CAMD Meeting Statement (The European Competent Authorities for Medical Devices (CAMD))
- https://www.camd-europe.eu/other/51th-camd-meeting-statement/
MDCG 2022-16: Guidance on Authorised Representatives Regulation
- https://health.ec.europa.eu/system/files/2022-10/mdcg_202216_en.pdf
New Notified Body EU MDR: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s (Czech Republic)
- https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320100&version_no=24
Training
December 12th until December 16th https://school.easymedicaldevice.com/product/gb
UK MHRA: Borderline products: how to tell if your product is a medical device: New section added ‘Risk classification of medical devices’
- https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device#risk-classification-of-medical-devices
Swissmedic: Plan to accept FDA products in Switzerland
- https://www.swiss-medtech.ch/en/news/politicians-decide-favour-patient-care
- https://par-pcache.simplex.tv/subject/?themeColor=AA9E72&subjectID=58905&language=de
Finland: Power blackouts do not require special preparedness measures from the users of medicines and medical devices
- https://www.fimea.fi/web/en/-/power-blackouts-do-not-require-special-preparedness-measures-from-the-users-of-medicines-and-medical-devices
Rest of the world
United States: EUA Template for Developers of Antigen Diagnostic Tests (MonkeyPox)
- https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices#templates
United States: MedSun Newsletter – November 2022
- https://www.fda.gov/media/162771/download
Canada: List of recognized standards for medical devices:
- https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance/list-recognized-standards-medical-devices-guidance.pdf
- Interesting as ISO 13485:2016 is not included.
Canada: November 8, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting
- https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/11-08-changes-reporting-medical-device-shortage.html
Bahrain: Reminder Regarding Deadline for Medical Devices and Supplies Authorized Representatives Registration
- https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular No. (35) 2022_To Medical Devices Importers and Suppliers_Deadline for Medical Devices Supplies Authorized Reps Registration_20221124.pdf
If you are looking for an Authorized Representative or Importer in the European area, contact us at EO@easymedicaldevice.com
PODCASTS:
- Episode 205: **Your Software/IVD clinical report is completely WRONG! https://podcast.easymedicaldevice.com/205/
- Episode 206: **Regulatory Pathway: How to reach the US market? [510k exempt] https://podcast.easymedicaldevice.com/206-2/
- Episode 207: **Why Risk Management is important to Medical Device development? https://podcast.easymedicaldevice.com/207-2/
- Episode 208: **How to choose the best Sterilization Method for Medical Devices? https://podcast.easymedicaldevice.com/208-2/
The post Medical Device News – December 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This is a questions that I get asked when I am part of the design process of medical devices. Which Sterilization method should we choose? I invited Jane Scally to help us define the best practices when it comes to the Sterilization process.
The post How to choose the best Sterilization Method for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Why is Risk Management so important? This is maybe something that a lot of regulators are asking you. "Do you have your Risk Management?" In this episode, we will explain to you why this is most critical information to get.
The post Why Risk Management is important to Medical Device development? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you are willing to reach out to the US there may be multiple strategies. We will talk today about MysteryVibe that started to evaluate the market and identified that their product is class IIa in EU and Class II in the US. But in the US this is 510k exempt so let's here their journey.
The post Regulatory Pathway: How to reach the US market? [510k exempt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you are in the Software and IVD industry we would bet that you are making your clinical data gathering wrong. Cesare Magri will explain to you why and how to correct that. So listen carefully to his advise.
The post Your Software/IVD clinical report is completely WRONG! appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What happened to the Medical Device industry? Let's learn in this episode with Monir El Azzouzi
The post Medical Device News – November 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
We are starting to get more and more questions on the PRRC and I think this episode will help you a lot to understand what your responsibility is when you sign a contract as PRRC. In this episode, I will talk with Elem Ayne, President of Team-PRRC. We will look at the questions that this association is receiving. We will also discuss the first Team-PRRC conference and what will be talked about during that event. Join us if you are in the region.
Who is Elem Ayne?
Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of the “DM Experts” network (in France). She started her career in R&D in microbiology, oncology, and biochemistry. She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality, and regulatory affairs for different industries, in particular in sterilization. She has finally specialized in Regulatory affairs working especially in Class I reusable granted a Master’s degree in this field before founding her own company “ACR Medical” to support manufacturers in their compliance with MDR (EU) 2017/745. She is also the President of the Non-for-profit association Team-PRRC
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- Elem Ayne Linkedin: https://www.linkedin.com/in/elemayne
- Team-PRRC event (non members): https://www.team-prrc.eu/collect/description/254458-u-team-prrc-annual-summit-event-in-brussels-in-3-4-november-2022-for-public
- Special price for members with this link: https://lnkd.in/ejHBcHDH
- Team PRRC event Program here: https://www.team-prrc.eu/
- How to become the best PRRC ever? https://podcast.easymedicaldevice.com/198/
- How to become a PRRC? https://podcast.easymedicaldevice.com/84
You are maybe asked to become a PRRC and you start to have a lot of questions. I am sure these are the questions that you ask yourself as this is also what other people are willing to know. They contacted Elem Ayne at Team PRRC and the association is trying to help them understand the situation.
The post Can you go to Jail as a PRRC? [Elem Ayne] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Within this episode, I will explain to you how you can be MDSAP certified for your Medical Devices. The agenda for this episode is the following:
- What is MDSAP?
- Which countries are included in MDSAP?
- Standards and legislation requirements
- How to integrate MDSAP into your QMS?
- Who can audit you for MDSAP?
- How to verify that you are MDSAP-ready?
Don’t hesitate to check the links below to find more resources to help you.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of Medical Device Regulations all over the world. He has now built the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- MDSAP blog post: https://easymedicaldevice.com/mdsap/
- Podcast episode MDSAP Angelina Hakim: https://podcast.easymedicaldevice.com/10/
- FDA MDSAP procedures: https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-audit-procedures-and-forms
- Audit Approach document: https://www.fda.gov/media/157947/download
- Shop MDSAP table: https://school.easymedicaldevice.com/product/mdsap-gap-assessment-tool/
- MDSAP Auditing Organization: https://www.fda.gov/media/155495/download
MDSAP is now in place since few years. For those that still have no understanding of it, I will tell you all on it from who needs it to how to be prepared for it. Enjoy!
The post How to be MDSAP certified for your Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Here is your Regulatory update. Don’t forget to check the show notes for all the links we will mention on this video.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Is company are also acting as Authorized Representative for EU, UK and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video
- Medboard regulatory links to the episode: https://www.medboard.com/reports/easymedicaldevice/regulatory-update/
- TRAINING EU MDR: https://school.easymedicaldevice.com/course/gb21
- Episode 197 – US importer with Stéphen Toupin https://podcast.easymedicaldevice.com/197
- Episode 198 – How to become the best PRRC ever with Ronald Boumans https://podcast.easymedicaldevice.com/198
- Episode 199 – How to select your Notified Body and understand the full process https://podcast.easymedicaldevice.com/199
- Episode 200 – Feedback from followers, stakeholder and customers. https://podcast.easymedicaldevice.com/200
This monthly episode will provide you with all the latest updates for the Medical Device industry in EU, UK, Switzerland, and the rest of the world. So don't miss it.
The post Medical Device News – October 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This week, we reached 200 episodes of the Podcast and I asked some of the stakeholders to share feedback on how this helped them achieve their objectives. I also asked some of my team members to tell me what their journey was since they are part of the team.
So today, this is the result of the feedback and I also wanted to thank all the listeners as this journey would not have been achieved without you. Thanks for your comments, and your nice messages.
So let’s meet who is behind Easy Medical Device as I am not alone.
Links
- Alex Despotovic Linkedin: https://www.linkedin.com/in/alex-despotovic
- Joanna Sandek Linkedin: https://www.linkedin.com/in/joanna-s-95524b10b/
- Anindya Mookerjea Linkedin: https://www.linkedin.com/in/anindya-mookerjea-6b5367209
- Cesare Magri Linkedin: https://www.linkedin.com/in/cesare-magri-92465345
- Ivan Perez Chamorro Linkedin: https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22
- Cristina Miroescu Linkedin: https://www.linkedin.com/in/cristina-miroescu-4255a6164
- Larina Olteanu LinkedIn: https://www.linkedin.com/in/larina-olteanu-505001216
- Odelia Zerbiv Linekdin: https://www.linkedin.com/in/odelia-zerbiv-a569484
- Lenny Tonnang: https://www.linkedin.com/in/lenny-tönnäng-23b55a64/
- Create an intended purpose with Cesare Magri: https://podcast.easymedicaldevice.com/65
- EU MDR lesson learned on clinical data with Cesare Magri: https://podcast.easymedicaldevice.com/171/
- eQMS with Anindya Mookerjea: https://podcast.easymedicaldevice.com/182
- Scube-Technologies Smarteye eQMS: https://scube-technologies.com/contact/
Social Media to follow
- ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- ■ Twitter:
- ■ Pinterest: https://www.pinterest.com/easymedicaldevice
- ■ Instagram:
This is the celebration episode for the 200th consecutive week where we released the podcast. This time I asked some of the stakeholders to provide a feedback about their experience with Easy Medical Device and the Podcast.
The post What do Clients, Followers, Team, … think of Easy Medical Device? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
I know you are struggling with that so I will explain to you what we learned applying to multiple Notified Bodies. This is difficult and you should really plan the process ahead and not wait the last minute.
The post How to select your Notified Body and understand the full process? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The selection of Notified Bodies in Europe can be a real challenge and I will explain to you in this Podcast episode how to do it so you can understand the process and get the real outcome for your projects.
There are 33 Notified Bodies for EU MDR 2017/745 at the time of this podcast. This is lower than the number of Notified Bodies that were under EU MDD 93/42/EC so this means that there will be a big bottleneck. So let us help you go over it and really make the right decisions.
To get all the information about this process with Notified Bodies, go to the Annex VII of the EU MDR and IVDR
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company is also acting as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- NANDO Database: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
- First audits conclusion episode with Martin Witte: https://podcast.easymedicaldevice.com/140/
- Qualitiso Notified Body price: https://www.qualitiso.com/en/comparison-of-notified-body-fees/
- EU MDR link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128#tocId166
- Technical File Episode: https://podcast.easymedicaldevice.com/191/
- Expert Panel Episode with Bassil Akra: https://podcast.easymedicaldevice.com/102/
- First results of Expert Panel Episode with Bassil Akra: https://podcast.easymedicaldevice.com/136/
- TÜV SÜD pre-application form: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration
Becoming the best PRRC ever is something that all PRRC should go for. The PRRC role is really important to avoid some situations that happened like the PIP scandal or recently the Philips issue.
PRRC means Person Responsible for Regulatory Compliance and this is a mandatory role within the Medical Device industry. So if you still have no PRRC within your company then this can be a problem. So learn more about it.
Ronald Boumans will help us understand what should we do to become the best PRRC ever.
Who is Ronald Boumans?
Ronald Boumans has seen the medical devices field from almost every corner thinkable (R&D, distribution, research, certification, standard development, market surveillance, policy making, stakeholders representation, and consulting), so he can approach most challenges from multiple angles. This helps the organizations he works with to adapt their approach to their challenges and keep full control over their processes. The ability of thinking out of the box is a precious added value in the field of regulatory compliance. Graduated as an engineer in industrial design at the Technical University of Delft in 1986, Ronald started his career in R&D for medical devices (including package design). He then moved to importing and distributing devices in The Netherlands, followed by quality research and rearch into the relation between medical devices and quality of life. This brought him to work for the Dutch competent authority as a senior inspector for medical technology. In 2013 he became a senior regulatory consultant at Emergo. In 2022 he started his own consulting company.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- Boumans Regulatory Consulting website: https://boumansconsulting.com/
- Ronald Boumans LinkedIn: https://www.linkedin.com/in/ronald-boumans-34790055/
- Team-PRRC Annual Meeting: https://www.team-prrc.eu/collect/description/254458-u-team-prrc-annual-summit-event-in-brussels-in-3-4-november-2022-for-public
- Team-PRRC website: https://www.team-prrc.eu/page/1111392-presentation
- PRRC Video LinkedIn Live: https://www.youtube.com/watch?v=RHRI9UjEdjs
PRRC is a 4 letters acronym for Person Responsible for Regulatory Compliance and you need a person to act as PRRC but also a person that can really understand how to become the best PRRC. So let's learn more about it on this podcast episode.
The post How to become the best PRRC ever? [Ronald Boumans] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This is not anymore a question, you need an Importer for the US market. But what are the rules and who can do this. Stéphen Toupin from Dawa Medical will help us understand why your products are blocked at the US Customs.
The post Why do you need an Initial Importer for the US Market? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
You get a call from the US Customer border which are telling you that your products are blocked. Why that? Maybe because you have no importer defined for these products. And this is what we will explain to you today on this podcast episode. Stéphen Toupin from Dawa Medical is helping those manufacturers by being their Initial Importer and he will tell you what you should do to remain compliant.
Who is Stéphen Toupin?
Over the last 27 years, Stéphan has gained a wealth of experience in the Medtech and pharmaceutical industries with Astra Zeneca, Biovail, and Novo Nordisk. Stephan founded Dawa Medical in 2015 to collaborate with foreign MedTech manufacturers to enter and succeed in the massive US market. Dawa Medical is a United States Initial Importer and FDA agent, with warehousing and distribution capabilities. Dawa Medical also offers services for the Canadian and Latin American markets.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- Stéphen Toupin LinkedIn Page: https://www.linkedin.com/in/stephantoupin/
- Dawa Medical LinkedIn Page: https://www.linkedin.com/company/dawa-medical-llc/
- Dawa Medical Website: https://dawamedical.com/
- FDA Initial Importer: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
- FDA 21 CFR part 803: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=807.3
Medical Device News is your summary of what happened in the Medical Device Field. I am providing you with the September 2022 Regulatory Update. Enjoy!
The post Medical Device News: September 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Here are the links to the Regulatory Updates
HOT TOPIC
- EUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf
- EU Call for application submission of EU Reference laboratories. https://health.ec.europa.eu/latest-updates/call-eu-reference-laboratories-sent-member-states-2022-08-05_en
- HPRA & Spain – EU Commission call for Member states application of EU Reference labs for IVDs (EURLs) – http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/european-commission-publishes-call-for-european-union-reference-laboratories-for-ivds-designation&id=619f1226-9782-6eee-9b55-ff00008c97d0
- https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/instrucciones-para-la-presentacion-de-solicitudes-de-designacion-de-laboratorios-de-referencia-de-la-ue-para-productos-sanitarios-de-diagnostico-in-vitro/
- Belgium FAMHP: https://www.famhp.be/en/news/call_for_belgian_laboratories_to_apply_to_become_the_european_union_reference_laboratory_for –
- Clinical Evaluation Consultation Procedure
- CECP Class III implantable tricuspide valve procedure https://health.ec.europa.eu/latest-updates/expert-decision-and-opinion-context-clinical-evaluation-consultation-procedure-cecp-2022-08-24_en
- CECP 2022-000213 Transcatheter heath valve https://health.ec.europa.eu/document/download/3ed8dacb-2b9d-4096-bc84-0b408f8492c4_en?filename=cecp-2022-000213_opinion_en.pdf
- Draft Reclassification of Annex XVI products https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
ROW
- SFDA introduction to regulation Workshop – REMOTELY: https://www.sfda.gov.sa/en/workshop/87146
- SAHPRA Guidances on clinical trial
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-07_v4-Guideline-for-Post-Clinical-Trial-Access.pdf
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-06_v2-Guideline-for-The-Procedure-of-Consultation-Meetings-with-Clinical-Trial-Applicants.pdf
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-04-Oversight-and-Monitoring-in-Clinical-Trials_August-2022_V4.pdf
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-03-Emergency_Procedures_Clinical_Trial_Sites_August-2022_v3.pdf
- China – Guidance for registration of percutaneous Enteral Nutrition Catheter and Disposable Human Arterial Blood Samplers https://www.cmde.org.cn/flfg/zdyz/zqyjg/zqyjgwy/20220826111515137.html
- India: List of certified Medical Device Testing Laboratories under MDR 2017 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg4Mg==
- Australia TGA – Regulatory Guidelines for Medical Devices https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd
TRAINING
- Green Belt Session 20: https://school.easymedicaldevice.com/product/gb/
- Scube Technologies: https://scube-technologies.com/
NOTIFIED BODIES
- 32nd NB MDR – Bureau Veritas Italia https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=318721&version_no=15
GUIDANCES
- MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
- MDCG 2022-14 Transition to the MDR and IVDR: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf
EASY MEDICAL DEVICE PODCAST
- Medtech Europe Forum Interview https://podcast.easymedicaldevice.com/188/
- AI Act Erik Vollebregt https://podcast.easymedicaldevice.com/189/
- Cleanroom Philippe Bourbon Icare https://podcast.easymedicaldevice.com/190/
- How to create a Technical File https://podcast.easymedicaldevice.com/191/
- When you think 510k but FDA says DeNovo with Spencer Jones Lineus Medical https://podcast.easymedicaldevice.com/192/
- Discontinuation process with Alexandros Savvidis https://podcast.easymedicaldevice.com/193/
- New Blue Guide Erik Vollebregt https://podcast.easymedicaldevice.com/194/
- SaMD and SiMD Design Dossier Anindya Mookerjea https://podcast.easymedicaldevice.com/195/
The Design Dossier of your Medical Device is really important. But what about a Software as a Medical Device. You will learn today some good practices to create them.
The post SaMD or SiMD – How to create your Design Dossier? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The New Blue Guide is a guidance document that is really important to CE marking. And this has also some impact on the interpretation of the Medical Device legislation like EU MDR and IVDR. So don't miss this episode where we interpret what are the major changes.
The post New Blue Guide – What is the impact on Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Why are you not discontinuing your products? I am not talking about just deleting the reference on your portfolio but obsoleting the documents linked to this product.
The post Why are we not Discontinuing your Products? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What would you think if you planned all your regulatory strategy for FDA 510k and when you submit, the FDA says to you that this should go DeNovo. Spencer Jones will tell us what he learned during this process.
The post When you think “510k” but FDA says “DeNovo” with Spencer Jones appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
I get a lot of messages about the creation of Technical Documentation and I want to share with you how I am doing it. Don't hesitate to check the link in the show notes for more details.
The post How to create your Technical Documentation? [EU MDR and IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The use of a cleanroom is something that depends on your products. Philippe Bourbon from the laboratory Icare will explain to us what exactly is needed to install and maintain cleanrooms.
The post Maybe you need a Cleanroom? Let’s check with Philippe Bourbon appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you are working with Artifical Intelligence for your Medical Devices, then this episode is for you. We are alerting you about the new legislation that is planned for all Artificial Intelligence software. Not only medical devices, but they are included.
The post AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
During my visit to the Medtech Europe Forum I had the chance to meet Fabien, Peter, Ronald, Inna and Rana. They shared with me some great information. Don't miss their interview.
The post Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This podcast episode is the monthly review of the regulatory situation. Don't forget to download the document with all the links.
The post Medical Device News – July 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This is your last year to be compliant to UKCA otherwise Bye Bye the UK market. We tell you everything with Adam Rae on this episode. So listen carefuly and don't forget to download the cheat sheet.
The post Attention! 1 year before UKCA is the law for Medical Devices in the UK appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
We may think that ISO 13485 certification is only for Medical Device manufacturers but in this episode you will hear Cristina Miroescu from Sofmedica Group tell us why its company decided to be certified even if they are not manufacturing devices.
The post Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Karandeep Badwal will list us some of the common mistakes that he has always noticed. I will confirm some of them. If you are able to solve those you have made already 70% of the problems resolved. Enjoy!
The post What are some Quality Common Mistakes? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical device news June 2022 is focusing on IVDR 2017/746 date of applciation and consequences. Don't miss all the additional information on guidances, Training,,,
The post Medical Device News: June 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
We have worked since more than a year on an eQMS called SmartEye and I have invited Anindya Mookerjea the CEO of SCube Technologies to present the tool and talk about the advantages of electronic Quality Management Systems.
The post Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medtech Forum was really a great event with all the Medical Device stakeholders at the same place. Manufacturers, Consultants, Notified Body, European Commission, trade associations, service providers. Let's summarize that with Erik Vollebregt.
The post What to learn about the EU Medical Device situation? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The IVDR 2017/746 will go live and this may be a big problem for a lot of companies. We will talk about that with Colm O'Rourke from Trinzo. The IVDR is changing the game so learn about it.
The post What happens after the IVDR Date of Application with Colm O’Rourke appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Software as a Medical Device is an area that is exploding. So understanding how this is working and what to be done is important. Listen to this episode to have more clarity on your projects for EU and US.
The post How to certify your Software as a Medical Device? (SaMD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode, we will review all the changes related to Quality & Regulatory Affairs for Medical Devices in the month of May 2022.
The post Medical Device News: May 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Great episode with Rod and Katie on Training Requirements. A lot of afvices that can help you pass audits and remain compliant
The post Training Process – What are the mistakes to avoid? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This podcast episode will be instrumental for you as PMCF should be part of your strategy. And Matthias Fink from TÜV SÜD will provide you with great advice on how to overcome this task.
The post How your PMCF is evaluated by your Notified Body? [Matthias Fink] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Have you ever performed an audit with a Front Room and Back Room? In this episode I will explain to you how this works and what is the interest. This method can help you to have a smooth audit and make your auditor happy.
The post How to prepare an Audit with a Front Room & a Back Room? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The latest news for the Medical Device Community is on the Medical Device News Podcast. We'll talk about EU, US, MEA, Asia, Notified Bodies, Events, Podcasts. So enjoy!
The post Medical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
We update you on the situation regarding the MDR and IVDR transition period. Erik Vollebregt will try to provide an explanation why the EMA will now take the control of the Expert Panel for Medical Devices and also why the proposal for a 2 years or more additional transition will be needed.
The post What are the surprises during MDR & IVDR transition? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you are selling medical devices online or if you plan to sell some, then this episode is for you. This will help you to understand the struggle that you may have or will encounter. Michael Wetherington and I will provide you the keys to be successful in that field.
The post How to sell Medical Devices online in the EU and US? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you are not sure of your Clinical Evaluation, then maybe by listening that you will have a better understanding of what is expected from you. So don't miss the lesson learned with Cesare Magri
The post What lesson did we learn doing Clinical Evaluations? [Cesare Magri] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
You will hear more and more about IVDR and now we talk of the Draft Common Specification. Have a look at the explanation from Andreas that will help you be more efficient if your products are on scope.
The post Why do we need the Common Specification for Class D IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This month the big news is about FDA amending QSR to integrate ISO 13485. Not sure on how this will be at the end but it's always cool to have harmonization. No worries, other topics like IVDR, MDCG, UK, Saudi Arabia, Spain are mentioned. Enjoy!!!
The post Medical Device News – March 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What is the role of a Swiss Authorized Representative and Swiss Importer? And most importantly why would you need one? I'll tell you everything on this podcast episode.
The post Why would you need a Swiss Authorised Representative and Importer? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Management Review is one of the most important activity to perform before to be ISO 13485 certified. So today I will explain to you how to be great at it.
The post How to be great at Management Reviews? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
DHF is an accronym that people don't really understand and in this episode Alexandros Savvidis he tries to help us have a view of his experience.
The post Why Design History File (DHF) is so important? [Alexandros Savvidis] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
All the February 2022 updates on MDR and IVDR, Clinical requirements and some news on the guidances and Notified Bodies.
The post Medical Device News: February 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The use of certain wording can be a big problem and this is what we will describe here with this MDCG guidance that is not really clarifying the situation but creating more problems. Let us tell you.
The post MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What is your method to perform an interview? You are not trained as a recruiter so how should you do to interview a QA RA Candidate. This is what Mitch Robbins will explain to you on this episode. So no more misses.
The post How to interview your QA RA Candidates? [Mitch Robbins] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Lab Tests can be really tricky for the success of your Medical Device Design. We will help you in this episode to understand with Christoph Lindner. Check show notes for more details.
The post How to accelerate your Laboratory Test Results? [Christoph Lindner] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
HAPPY NEW YEAR 2022! Another year passed and this went really fast. But the Medical Device News is still here. So today we will talk of all the releases done in December 2021 and what is planned for the following months. Don't miss it. This will save you a lot of time.
The post Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
I know, already the end of 2021. So many things happened that this may be difficult to summarize. So I've tried to put my TOP information on this episode. I also share with you the new projects for Easy Medical Device so don't hesitate to contact us if you need our support.
The post What happened in 2021? Summary for the Medical Device Industry appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
For this christmas season, I wanted to summaries the situation on how to get MDR & IVDR certified. So i made this step-by-step recipe where you just need to follow. I hope you'll enjoy.
The post The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you are not aware, the EU MDR 2017/745 is completely changing the definition of Custom-made devices and this is mainly what we will try to explain to you on this episode. If you still have some question,s don't hesitate to contact me.
The post Which devices cannot be Custom-made? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Here is the last Medical Device News for this year, I will cover all the updates that happen in the EU, UK, Switzerland,, US and Saudi Arabia. We will also review the situation for Notified Bodies. I hope you'll enjoy.
The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The MDR classification was hidding some surprises and I have asked Frank Matzek from Biotronik to tell us more about the products and rules we need to take care of. So Enjoy!
The post Let’s unleash “MDR Classification surprises” [MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Really great discussion with Dr Royth von Hahn from TÜV SÜD. He is providing some solutions on how to talk to your Notified Body. This would help Medical Device manufacturers.
The post How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
OEM OBL is really used a lot by Medical Device Manufacturers. But this is not possible anymore with EU MDR. So please listen to that as maybe you are doing it without knowing.
The post Is it possible to Private Label a Medical Device under MDR & IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Lesley Worthington is a career coach and will help you understand why improving your communication skills within QA RA can be a booster for you. We will talk about our experience as she also worked in QA RA. So don't miss this episode if you don't understand why your communication activities are not helping you.
The post How to improve your QA RA Communication with Lesley Worthington? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Latest update will focus on IVDR proposal, Artificial intelligence, Notified Bodies situation and MDCG guidances. Other elements will also be discussed. I hope you'll enjoy!
The post Medical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
BREAKING NEWS: The EU Commission issued a proposal to delay some IVDR date of application but it is not a complete postponment so don't use this word. Listen the interpretation of Erik Vollebregt on that.
The post How does the EU Commission plan to save IVDR 2017/746? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Ana Luiza is my guest and we will explain to you how to be sure that your are compliant with CMR substances on your product. CMR will be reviewed during an audit and apparently there were a lot of mistakes. So let's help you to avoid that.
The post How to comply with MDR when products contain CMR Substances? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
EUDAMED is the database that will provide all the information about your company and your devices. After the release of the Economic Operator module, now there is the release of the Device Registration and Certificate Module. So let's talk about that with Richard Houlihan from Eudamed.com
The post EUDAMED Update: Should you register your medical devices now? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Here is the Regulatory update for October 2021. We will talk of the Implementation of MDR and IVDR, MHRA, Swissmedic, FDA, AEMPS.. A new session of the Green Belt opens this month.
The post Medical Device News – October 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The MDR and IVDR has not finished to surprise us. On this episode we will talk about the article 16(4) where we see that in certain circumstances, an importer or Distributor will need to get certified by a Notified Body even if they are not doing a manufacturing activity. So don't miss that.
The post Why does an Importer/Distributor need to appoint a Notified Body? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Are you starting a clinical investigation or PMCF? Then are you using a Digital Solution to collect the data? Today we will explain to you what is
The post How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
We have passed the Date of application for MDR and this went well because a lot of manufacturers do have CE certificates that expire later. But for IVDR this is another story. So for the majority of the products, they should be compliant by the date of application. Let me explain that to you on this episode.
The post How to manage the IVDR transition period? [IVDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Maybe some of dreamed of it, maybe this idea went through your mind but you haven't done it. Here we will talk with Erik Vollebregt of the consequences of opening a legal case with your Notified Body.
The post Is it a good idea to sue my Notified Body? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
On this September 2021 update we will talk about FDA, MHRA, Swissmedic, ANSM, Fimea, MDCG guidances, New Notified Bodies... A lot to talk about so don't miss this update. If you are not willing to read the guidances, let me summarize it for you.
The post Medical Device News – September 2021 Latest Updates appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
There are a lot of questions about Software as Medical Devices. So I have invited Dr. Abtin Rad from TÜV SÜD to give us more information about how to consider SaMD with the EU MDR 2017/745
The post How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This is a question I asked myself when I started my career. I am now an independant consultant but I started as a Full-time employee. So Smahan will help us understand which option can be the best for you.
The post Better to be a Consultant or a Full-time employee? [Lifescience industry] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
We talked a lot about MDR and tried to teach most of its requirements. And today we will continue by providing you with the Most Common Mistakes that are discovered by Notified Bodies. Martin Witte from TÜV SÜD will share with us the issues that are discovered by its team. Let's learn from it.
The post What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This is already Mi-Year with the summer holiday. But EU Commission didn't sleep as there was a lot of MDCG guidance released. Let's review the agenda for this month and don't miss all the links. The post Medical Device News – August 2021 Regulatory Update [MDR & IVDR] appeared first on Medical Device made Easy Podcast.
Vigilance Reporting is an important system to have within your quality management system. Even if you are still MDD, you need to comply to the MDR requirements for it. So I will help you for that.
The post How to implement Vigilance Reporting for MDR and IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
After receiving a lot of questions on System and Procedure pack we have decided to have a second episode on it with Erik Vollebregt. So let's review some special cases and also some feedback from the authorities.
The post System and Procedure Pack the RETURN with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Bassil Akra will help use interpret this first Expert Panel Opinion. Bassil already helped on a previous episode where we discussed about the creation of this Expert Panel. Let's review this first outcome and see the consequence of it for the industry.
The post How to interpret the first Expert Panel Opinion? [Bassil Akra] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
We will update you on all what happened within the Medical Device regulation. All new
The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The State-of-the Art is one of the component that can make you win or make you lose. If this research is not done correctly, it can ruin your Clinical Evaluation Report or Performance Evaluation Report. Hakan Inan from Requalite will explain to us why this is important.
The post How to build your State-of-the-art for your Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In the case you are placing your brand trademark on a product, or if you buy a product designed by another company... then you need to understand the rules related to Intellectual properties. This episode with Stephen Carter will be a masterclass about Intellectual Property.
The post How Intellectual Property is linked to the Medical Device Regulation? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Clinical Investigation is not really an easy process. So it can be important for your to understand what are the requirements and get some details about time and cost. Helene Quie from Qmed Consulting which is also a CRO will help us learn more about this process required by EU MDR.
The post How to perform a good Clinical Investigation with Helene Quie appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This podcast episode is really important as this answers some of the questions that a lot of my customers are asking. So I hope this will help you to understand why this is important to perform a Biological Evaluation or Biocompatibility for your finished product.
The post How to perform a Biological Evaluation for your Medical Device? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News June 2021 Update is providing you all the last updates. This IS the episode of the EU MDR date of application. A lot of news provided.
The post Medical Device News – June 2021 Update [EU MDR Date of Application] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
EU MDR is starting tomorrow and we wanted to check the situation for Economic Operators. We had already interviewed Catherine on the previous survey release. This time we do a follow-up
The post EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 week to the EU MDR and we hope that you are ready. If not, then you can maybe listen to this episode as we are answering some last minute questions.
The post MDR is coming so brace yourself with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This process called EUA was really famous last year when everyone wanted to register its face mask or respirator or covid-19 test in the USA. After 1 year let's see the conclusion of Michelle Lott on it.
The post FDA: Is the Emergency Use Authorization worth it? (EUA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This is the last month before the EU MDR 2017/745 Date of Application. We will talk about that and about all the updates
The post Medical Device News – May 2021 Update [EU MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
It is Day -30 for the EU MDR date of application. So let's summarize what should be ready for you and also what is not mandatory.
The post Checklist – What is important before the EU MDR Date of Application? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Merger and Acquisition is an important topic to understand as people think this is a fiance activity. But when you'll listen to this episode, you will not think that anymore.
The post How to perform correctly a Merger & Acquisition during the MDR transition? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode Hakan Inan will help us to write our Performance Evaluation specifically for IVD products.
The post How to write your Performance Evaluation? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode, we will summaries what happened for the Medical Device Community. We will explain to you the last MDCG Guidances that were issued and the Notified Bodiy Situation.
The post Medical Device News – April 2021 Update [EU MDR & IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
IVDR is planned for May 26th, 2022 but why it will be more difficult for IVD manufacturers than for MDR manufacturers? Listen to this episode to have a better understanding
The post Will it be really difficult for IVD manufacturers? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
During the Greenlight Guru summit on EU MDR & IVDR I have presented the way to create a label. And following the session there was so many questions that I decided to answer to some of them within the Podcast so everyone can benefit from it. So I hope this will help.
The post How to create a Label under MDR? (Questions & Answers) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The system and procedure pack within EU MDR is still a mystery for a lot of people and Erik Vollebregt accepted to help us have a better understanding of this specific cases. We will explain to you what it is and who can use it.
The post How System and Procedure Pack are regulated under EU MDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode, Edgar Kasteel will help us understand the role of an importer and will also tell us more about the model of independent importers.
The post How to import your Medical Devices with an Independent Importer? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this monthly episode we will review what happened within the Medical Device industry. EUDAMED, Covid19, Notified Bodies...
The post What is the Medical Device News? [March 2021 update] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Waterfall or Agile? Jon Speer from Greenlight Guru will help to understand what is the best methodology that can be used to develop your medicaldevices.
The post The best design methods for successful development? [Jon Speer] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to find a job in the QA RA world for Medical Devices? This is what we will discuss with Karandeep Badwal. We will provide our tips and also the platforms to visit. The post How to find a QA RA job for Medical Devices? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast.
If you are thinking that you are the only one that has issues as QA RA, then listen to this episode. I hope this will help you to understand that there is a certain mindset to have when you do this type of job. The post What is the QA RA Mindset with Michelle Lott appeared first on Medical Device made Easy Podcast.
On this podcast episode, we'll perform the February 2021 update. What happened in the Medical Device World. One of the HOT TOPICS is the Remote audit authorization by the EU Commission but we'll see this is not so easy. The post February 2021 Update – Medical Devices Remote Audit by the EU appeared first on Medical Device made Easy Podcast.
PMS is an action that take some hours to perform. But with all the information generated, it get worse and worse. So I have invited Ivan Perez Chamorro, the Founder and CEO of Medboard to help us understand how we can love to perform PMS within our companies. Medboard has the solution.
The post How to perform your PMS more easily with Ivan Perez Chamorro? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The new EU MDR is now taking into account dangerous Software as a Medical Device SAMD. In this episode we will talk specifically about Artificial Intelligence Software. How to make them safe and efficient to be EU MDR certified? Listen to know. The post How to get the MDR certification for Artificial Intelligence Softwares? appeared first on Medical Device made Easy Podcast.
Liat Nadel is the CEO of L.S. Marketing & Registration. She will help us to understand the context for the registration of Medical Devices in Israel. The post How to register a Medical Device in Israel? (Liat Nadel) appeared first on Medical Device made Easy Podcast.
In this first episode of 2021 we provide you an update of the Medical Device Regulation situation. We will talk about Brexit, Swixit, Turkxit, MDCG, Notified Bodies, Approved Bodies, Trainings, Podcast... A lot to cover.
The post Medical Device News – January 2021 Update (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This is the last episode of 2020 and I wanted to share with you the progress of the Easy Medical Device project. I will also tell you the next steps that I will try to achieve. Let me know how I can help you? The post How Easy Medical Device can help you? (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast.
Martin Witte from TÜV SÜD will help us to understand the significant changes to your devices and the consequence of it for your CE Certificate. You will have to listen carefully if you are selling medical devices on the EU market after May 26th, 2021 under your EU MDD certificate.
The post How to deal with Significant Changes within MDR & IVDR with Martin Witte appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
You maybe know how to register your devices in Europe or USA now. But let's discover how we can do that in Mexico with Josué Garza from IPS or Insumos para la salud. You'll learn the 3 pathways to do that.
The post How to register a Medical Device in Mexico? [Josué Garza] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This November update is providing a lot of information on what you should not miss. We will talk Brexit, Eudamed, Jobs, Training... A lot of topic to help you stay up-to-date. The post Medical Device News: What happened in November 2020? appeared first on Medical Device made Easy Podcast.
In this episode, we will hear the journey of a Notified Body to get EU MDR accredited. We hope this will help you to understand how difficult it is and why you should be patient with your Notified Body. The post Is it Easy for a Notified Body to get EU MDR accredited? appeared first on Medical Device made Easy Podcast.
In this episode, we will tell you why this is important to invest on trainings for your employees. I have invited a company that participated to the Green Belt Certificate and I asked them to tell us what they have implemented after taking this training.
The post How a Quality & Regulatory training can help you? [Sofmedica] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you thought that clinical evaluation was already difficult to work on with the new EU MDR, then listen to this episode where we will tell you about the new level of difficulty that is coming soon. The post Do you need an Expert Panel for your Medical Devices? [Bassil Akra] appeared first on Medical Device made Easy Podcast.
Common Specifications are a type of regulation that we will explain to you in this episode with Stefan Bolleininger. The one on Reusable single use device was published. We expect more to come.
The post What are Common Specifications under EU MDR & IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
We have reached 100 episodes on the podcast and today we will celebrate that. Here is an episode with some of the great influencers in the Medical Device field which are sharing with us their journey. What happened to you since the last years. The post We’ve reached episode 100 – What happened for the last 2 years? appeared first on Medical Device made Easy Podcast.
Self-testing devices are already existing in the market and already mentioned under IVDD. But what does change with the new IVDR? Erik Vollebregt from Axon Lawyers will help us to interpret that.
The post How to certify a self-testing device under IVDR? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
EU MDR is a new regulation and if you have not started a project like that you need to understand that it is costing. Not only money but time, resource... So listen to this episode if you want to understand what you can expect from this type of projects.
The post What is the cost of EU MDR 2017/745? [Catherine Higginson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Michael Wetherington will by your instructor in this episode. He will provide you all the information to register your product in the ASEAN region. This is the countries located in the South East Asia.
The post How to register your Medical Device in the ASEAN region? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This month a lot of exists on the Medical Device news. We are still under a pandemic so conferences are going virtual and Easy Medical Devices has the best training for EU MDR.
The post The latest news on Brexit, Swixit and EU MDR [Medical Device News] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
ATMP is a category of product not so well known by the regulatory affairs professionals. I wanted to help you understand how they are working with Margareth Jorvid. She will provide us with a specific overview for ATMP-Device combination products.
The post How to register ATMP-Device combination products? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this case study we will see how Apos Therapy was able to register his product in the US for certain therapy. Cliff Bleustein; President and CEO of Apos Therapy is my guest today and you'll see that for a CEO he knows a lot about regulatory affairs.
The post How to get some help from Medical Device Regulators with Cliff Bleustein appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
GDPR is not specific to medical devices, but any judgment that is issued can impact devices. And this is the case with the SHREMS II case. Erik Vollebregt accepted to answer my questions on this technical topic to help us understand how to remain compliant.
The post How can GDPR impact Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The audit for a Medical Device company can be a real struggle if this was not correctly prepared. If you want to understand what a Notified Body is looking for when it is coming to your company, then you should listen to Martin Witte from TÜV SÜD. Who better than a Notified Body to tell you what a Notified Body wants to see.
The post Be successful at your MDR and IVDR audit with Martin Witte appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode we will talk about the UDI FAQ, the new regulation for reprocessing of single use devices, the EUDAMED actor module, the new Guidances released... A lot to discuss today.
The post Medical Device News – August 2020 Review (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Kevin Pay and Raluca Radu from TOPRA are helping us to understand how a virtual conference can bring the same type of experience as a normal one. This year the TOPRA Symposium will be virtual so you can assist to it without to travel. Let's listen how this will be organized,
The post How to switch quickly to a Virtual Conference with TOPRA appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device Testing is something all medical device manufacturers should perform. How can you prove that your device is safe and performing without that. So now how to do it? Michael Wetherington from Medical Regs will be my guest on this episode of the podcast. He will share with us all best practices.
The post Best practice for Device Testing with Michael Wetherington appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
IEC 60601 is one of the most important standard to look at if you have an electrical medical devices.
In this episode Leonard Eisner also called the IEC 60601 guy will help us understand the full situation. So be ready to learn a lot today.
The post Best overview of IEC 60601 for Medical Device electrical equipment appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this monthly update we will review some hot topics that happened within the last weeks., the Notified Body Situation, the Guidance and standards update and finally what happened at Easy Medical Device.
The post Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
UDI is new for Europe but already exist in the USA. We will explain to you what is important to understand for the EU version as there are some differences. Sylvia Reingardt from GS1 will be my guest and will share with us her knowledge and how GS1 can help.
The post Learn UDI code for Medical Devices with Sylvia Reingardt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What is IEC 62304? This is the question I asked Adnan Ashfaq from Pharmi Med Ltd. The answer is helping a lot to understand the interaction with other standards and regulations. Enjoy it!
The post Understand IEC 62304 for Medical Device Software with Adnan Ashfaq appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Team-PRRC is invited to this episode to help us understand how to become a PRRC. This is a new role required for Medical Device manufacturers. In this episode, we will also share with you what TEAM-PRRC can do to help you.
The post How to become a PRRC with TEAM-PRRC (EU MDR & IVDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
During this update, we will talk about the Coronavirus situation, the Notified Body accredited, the CEN CENELEC mandate for Harmonized Standards, the Green Belt Certification Program. A lot to say and also a Trailer for the EU Commission Telenovela.
The post Medical Device News – June 2020 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Shokoufeh from Straumann in Switzerland is sharing with us her journey on the EU MDR world. She will tell us what helped the team to reach this success and what she would have changed.
The post The secrets to being EU MDR certified with Shokoufeh Khodabandeh appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Process Validation is an important but difficult topic. You should not only be good at engineering but also at explaining to your staff. Because a good validation worth nothing if the Staff is not following the instruction. Listen to Monir El Azzouzi and Adnan Ashfaq sharing with you their experience.
The post How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode, I will help you understand the power of Internal Audits. Some of you are using that just because ISO is requiring it but you can get so much out of it.
The post How to execute your Internal Audits? (Medical Device companies) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The Month of May 2020 was supposed to be the beginning of the EU MDR. This was not as the new date is on May 26th, 2021. We will celebrate the Non-Anniversary of it and also talk about IVDR, MDCG, Notified Bodies, Coronavirus, Easy Medical Device podcast, LinkedIn Live... So be ready and push play.
The post Medical Device News – May 2020 Review with Monir El Azzouzi appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Sufficient Clinical Data is a new vocabulary introduced with the EU MDR 2017/745 but this is still unclear what is sufficient and what is too weak.
Bassil Akra from QUNIQUE Group will explain to you what you should do in the episode where a former Notified Body employee is giving you advises related to his experience. Bassil is also offering a webinar to people that want to learn more about sufficient clinical data.
The post What means Sufficient Clinical Data with Bassil Akra (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you are looking for a Notified Body for your Medical Device, you maybe have some difficulties to find one. In this episode, Bassil Akra from TÜV SÜD will explain to you the reason of this.
The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
I'll answer one of the most frequently asked question I receive from my followers. How to get ISO 13485 certified? Don't miss the links on the show notes to get more material to read.
The post How to get ISO 13485 certified? (Quality Management System) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
You are maybe a Digital Health Application developer, so this podcast will be of a great interest for you. If you don't place to make your device available in germany, than DIGA may help you change your mind. Listen to Stefan Bolleininger who will explain to you how your customers can get reimbursed.
The post How to get your Digital Health Application reimbursed in Germany? (DIGA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News April 2020- We will talk about how Coronavirus is shaking the Medical Device World, the Notified Body Situation, the MDCG guidances and the Easy Medical Device events. Enjoy!
The post Medical Device News – April 2020 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Don't worry, we will not show you any equation for calculating the sample size. But we will show you how to do it and why you should be careful on some important parameters. Then you can see some examples in the ebook provided by Jon.
The post How to calculate your sample size with Jon Bergsteinsson appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This week there was an important vote regarding the proposal to delay the EU MDR until May 26, 2021. The parliament adopted it and we wait for the publication on the official journal. But what will be the consequence for Medical Device Manufacturers, Notified Bodies...
The post The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you are not working in QA RA you maybe don't understand this. But sometime people don't want to follow the process not because they want to annoy you but because they are afraid of some consequences. And they try then to find other ways. Let's explore them with Karandeep Badwal
The post Medical Device School – Why are Staff hiding problems to QA & RA? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Did you know that the EU MDR is amending 2001/83/EC for Medicinal Products. This may have some consequences for your products if it involves a Drug-Device combination. Monir El Azzouzi and Theresa Jeary are explaining to you what should be done.
The post MDR & Drug-Device Combination Products with Theresa Jeary appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The month of March 2020 is over but there was a lot of information provided regarding the Medical Device industry so let's listen to the different news with Monir El Azzouzi
The post Medical Device News – March 2020 Review (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This is an important question if you understand the rule for a transition period of your device under EU MDR article 120(3). If you perform a significant change then you may be prepared for the consequences. Let's see what are the advice of Erik Vollebregt if you reach this situation.
The post What is a Significant Change for your Medical Device? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode we will focus specifically on Medical Device class I that are "Sterile", with measuring function" or "Reusable surgical instruments". Elem Ayne will help us to understand what you should prepare to be compliant.
The post All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Do you recall those movies with hackers that are taking the control of an hospital or of your pacemaker. Is this Science Fiction or reality. On this episode, Monir and Erik will explain to you how to secure your medical devices if they are connected to a network.
The post Cybersecurity for your Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode, we will talk about, Coronavirus, MDCG, Notified Body, US guidance, Podcast episodes, LinkedIn Live... So don't miss it.
The post Medical Device Regulatory Update – February 2020 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
It is clear that a Manufacture of a Medical Device need to have a Quality Management System. But what is the answer for an importer, Distributor or Authorized Representative? You'll hear it on this episode where Erik Vollebregt will help us understand the requirements of the regulation.
The post Do your Economic Operators need a Quality Management System? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The intended purpose of your device is critical but a lot of manufacturers are nor really putting much effort to write a good one. Check on this episode with Cesare Magri why this is important and how to create it correctly.
The post Create your intended purpose with Cesare Magri (Medical Device) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Your Economic Operators do have some responsibility per EU MDR and IVDR. What should they check? Monir El Azzouzi and Erik Vollebregt will help you understand that on this bonus episode.
The post Medical Device School: What should verify your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Many medical device manufacturers try to solve a puzzle regarding their Low risk medical devices. How to write Clinical Evaluation for it without data? here is the solution. Download the presentation.
The post Clinical Data for Low Risk Medical Devices with Robert van Boxtel appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode we will explain you the way that Economic Operators are controlled. This may seem obvious but the answer can be different per Economic Operator. So listen to this short episode of Medical Device School to understand everything.
The post Medical Device School – Who controls your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Brexit, Swixit, Turkxit. These are the topics of this episode of the Podcast. We will try to help you understand all these -XIT and what is the impact to Medical Device manufacturers.
The post Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Who are the Economic Operators mentioned on the MDR and IVDR? This is the question that Monir El Azzouzi and Erik Vollebregt will try to answer.
The post Medical Device School – Who are your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Swixit or not Swixit? is an alert to Medical Device Manufacturers regarding the political game that is played between Europe and Switzerland. Let's see the impact for the Swiss market but also for the EU market.
The post Swixit or not Swixit? this is the question with Ronald Boumans appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Process Validation or Verification? Some people are mixing both concepts, this is why Monir and Stefan will help you understand when to use one or the other.
The post Medical Device School – Process Validation or Verification? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This episode will be dedicated to provide the regulatory updates that happened on January 2020. This will help you to stay up-to-date.
The post Episode 61 – Medical Device Regulatory Update: January 2020 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
As Tania is saying this is the best time to export your products to Brazil, so we'll teach you how to register your products there. Enjoy!
The post How to register your Device in Brazil with Tania Aprigliano? (ANVISA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Quality and Regulatory affairs is not really a job that everyone want to work in. But this is maybe you didn't listen to the right arguments. Check what Monir El Azzouzi and Karandeep Badwal want to say.
The post Why is it Awesome to work in a Quality or Regulatory affairs job? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
MDR is requiring to create a Quality Management System but how to do that. This is what you will learn with Monir El Azzouzi and Stefan Bolleininger.
The post How to create a QMS compliant to MDR with Stefan Bolleininger appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Michelle Lott is my guest and will help us understand the 510k registration process with the US FDA. Should you use it? Is this changing? Learn everything in 1 episode.
The post How to register your Medical Device through 510k with Michelle Lott appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How should you audit your suppliers? Should you do the same as a Notified Body? Monir El Azzouzi and Stefan Bolleininger are providing you their opinion.
The post Medical Device School: How to audit your Suppliers? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
PMCF is a key element of the Post-Marketing Surveillance process. As there were a lot of questions about it then I decided to ask Helene Quie some questions while I was at Medica 2019.
The post Post-Marketing Clinical Follow-up with Helene Quie (PMCF) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This is the last episode of 2019 and I wanted to summaries the situation and introduce you to my 2020 projects.
The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
With the MDR, more and more clinical data are needed. But how will you collect them. David Rutledge will show you 6 ways to collect those data and the pros and cons for each of them.
The post 6 ways to collect Clinical Data with David Rutledge appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Before to look at this episode, you should go to Part 1. On this second part we'll continue to discuss Class I up-classified situation and then pure Class I devices under MDR.
The post Class I Medical Devices under MDR with Erik Vollebregt (PART 2) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The MDR Corrigendum 2 is changing the rules for some class I devices under MDD that are up classified under MDR. Let's see what manufacturers should do.
The post Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
If you have a product and you want to evaluate if this is a Medical Device, then you need to follow the 3 steps that we will discuss on this episode. Heikki Pitkänen's platform is providing a solution for your to evaluate your device and he offers it for free to the listeners of this podcast. Thanks to him.
The post How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What is the role of a Distributor within the new MDR 2017/745 and IVDR 2017/746. This is the question that I asked my guest who is working as distributor of Medical Devices in Norway.
The post Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
When you are trying to create your product there is one question that you should answer: Should you focus on your product development or your documentation creation? Listen to our argument on this episode of the podcast.
The post Medical Device School: Product Development or Documentation creation? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
EUDAMED is delayed but what should do Medical Device manufacturers to continue be compliant. Richard Houlihan is a EUDAMED expert and will help us understand.
The post EUDAMED is delayed, so What? with Richard Houlihan appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
When creating your Clinical Evaluation Report or CER, you maybe need to perform a literature search. There is a certain method for that and we wanted to help you to understand it with Ed Drower from CiteMedical Solution
The post Literature Search for your CER with Ed Drower appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this Bonus episode of Medical Device School we will talk about Gap Assessment tools. You know that when there is a regulation or something that you should put in place, you need to perform a gap assessment. To check where you are and if you are compliant to where you want to be. Let'S see if you follow our discussion with Stefan Bolleininger.
The post Medical Device School: How to build a Gap Assessment Tool? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
After episode 47 on how to implement an eQMS, Jacob Sjorslev is now telling us how to validate an eQMS. This is something mandatory now since ISO 13485:2016. So listen carefully and download the giveaway,
The post How to validate an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
An eQMS can be a necessary tool for your Quality Management System. This is why it's implementation should be executed as a project. Jacob Sjorslev will be your instructor and tell what to do and what to avoid. And Jacob will also make you an offer at the end of the episode.
The post How to implement an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
On the Medical Device School segment, we will help you understand how to be better with your CAPA system. Stefan Bolleininger and Monir El Azzouzi are sharing with you their experience.
The post Medical Device School – Most important issues on your CAPA (ISO 13485) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Some signs are raising from Hospitals regarding disruptions on Medical Devices. What is exactly the reason. Stefan Krojer will share with us his experience and a solution he is developing.
The post Medical Device Disruptions at Hospitals with Stefan Krojer appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Justin Bushko from Concise Engineering will share with us 5 FDA Myths that exist on the Start-up world. Medical Devices Start-Ups should satisfy Investors and Regulatory, and this can create some strange assumptions. Let'S listen to that.
The post 5 FDA Myths for Start-Ups with Justin Bushko appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
GDPR is also important for the MDR regulation. As we are developing Medical Device application, we should also implement GDPR on our development. Jovan Stevovic from Chino.io will help us understand what it means.
The post GDPR & MDR for Medical Applications with Jovan Stevovic appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
There are many ways to register a Medical Device in the USA and I propose you to listen to Michelle Lott that will tell you the basics of the FDA regulations.
The post Register your Medical Device in the US with Michelle Lott (FDA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In-Vitro Diagnostic Regulation will come later and we have time. Maurizio Suppo do have another opinion and as he is really passionate about this topic he will be providing some golden advice that you should not miss. Even for non-IVD manufacturers as we will talk about a proposal if manufacturers cannot meet the deadline.
The post New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
On this episode I invited Natasha Bankowski that is also called the PMS Queen to help us understand the Post Marketing Surveillance for Medical Devices. You can also meet her at TOPRA Symposium 2019.
The post Learn Post Market Surveillance with Natasha Bankowski appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
This episode with Helene Quie from Qmed Consulting contains Diamond of Information. If you are lost regarding Product Equivalence for your CER, then you need to listen that and it will be clearer.
The post Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Networking at events can be a great experience or a disaster. On this episode we will help you to be prepared for it. We will use the TOPRA symposium as an example.
The post Episode 39 – Networking at Medical Device events with Lynda Wight appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How can you be considered the best candidate ever? This is what will be presented today by Mitch Robbins from the Anthony Michael Group. And learn also why he called his company with this name.
The post Episode 38 – Be the Best Candidate Ever with Mitch Robbins appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Let's not talk about theory but really about experience when we are looking for Usability tests and Human Factors. Sharon Ayd will share with us a project where she was able to use these notions to succeed.
The post Episode 37 – Usability & Human Factor with Sharon Ayd appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
PRRC means Person Responsible for Regulatory Compliance. With the new Medical Device Regulation it is mandatory to have one at your company. Let's review everything about this role and help you to choose the right person.
The post Episode 36 – How to choose your PRRC with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Digitalization of QA RA is a concept that many Medical Company didn't adopt. But what can they win if they engage on it? This is the topic of today´s episode.
The post Episode 35 – Digitalization of QA RA with Michael Kania appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Real World Data is more and more important with all the new devices that can collect them. Then what can we do with them and how to present them to a regulator.
The post Episode 34 – Real-World Data for Medical Devices with Alethea Wieland appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
One important piece of the puzzle for the new Medical Device Regulation is about Notified Bodies. More and more we receive the information that some of them decide to Lay Down Service. What are the consequences for manufacturers? What is a solution for them? Erik Vollebregt will be my guest on this episode.
The post Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Pakistan Registration requirements for Medical Devices have been improved and leave more opportunities for Manufacturers. Muhammad Sohail, will share with us the situation of this market and the steps to register your products.
The post Episode 32 – Pakistan Registration Process with Muhammad Sohail appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Finding your first Regulatory Affairs Job can be a challenge. And Karandeep Badwal knows about that as he followed this journey. He is now Regulatory Affairs Contractor. Karandeep wanted to share with the audience some tips to be able to find quickly your first job. So don't miss those actionable tips.
The post Episode 31 – First Regulatory Affairs Job with Karandeep Badwal appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The topic of Promotional Compliance is really important in the USA. As you will hear on this episode, advertisement is everywhere and most importantly, the advertisement for Healthcare Products.
The post Episode 30 – Promotional Compliance with Darshan Kulkarni appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Jason Lim will reveal to us what are the 5 steps to create a good Quality Management System or QMS.
The post Episode 29 – 5 Steps to create a QMS with Jason Lim appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How an OEM or Original Equipment Manufacturer can help the OBL (Own Brand Labeller) to continue business? Stefan Bolleininger from Be-On-Quality will help us on this second part of the Podcast.
The post Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The OEM and OBL model is under question with the new EU MDR and IVDR regulations. Stefan Bolleininger will help us understand how to continue to be compliant and continue business.
The post Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Andreas Stange from TÜV SÜD will help us be prepared for the new IVDR or In-Vitro Diagnostic Regulation. This is a game changer for the manufacturers as more products are on the scope of a notified Body certification.
The post Episode 26 – IVDR preparation with Andreas Stange appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
EUDAMED is the new European Database for Medical Devices and this is something that can change completely the world of Medical Devices. For the consumers and the manufacturers.
The post Episode 25 – EUDAMED secrets with Richard Houlihan appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Are you hiring contractors or consultants for your projects? Do you know the difference or do you know what are the myths about them? Thomas McMann from EPM Scientific is sharing that with us.
The post Episode 24 – Myths about consultants with Thomas McMann appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Alethea Wieland, President of Clinical Research Strategies will tell us what are the most important criteria to select a good CRO for your clinical trial project.
The post Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start a Clinical Trial or perform a Clinical Evaluation? I invited Alethea Wieland from Clinical Research Strategies to help us have a better understanding. She will help beginners in this area to learn about the fundamentals of clinical trials.
The post Episode 22 – Clinical Trial with Alethea Wieland appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to be experimented they should start somewhere. So how to do that? Samantha Alsbury from TOPRA will help us on this new episode.
The post Episode 21 – How to master Regulatory Affairs with Samantha Alsbury appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Blockchain for Healthcare is a new Technology. On this episode, Khuram Malik will tell us what is Blockchain and how Medical Devices can use it.
The post Episode 20 – What is a Blockchain with Khuram Malik appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Cyrille Michaud from MD101 Consulting is helping us to understand the new rule 11 to classify Software Devices in the European Union. This is a new rule so this creates a lot of discussion in the industry. Let's clarify that with Cyrille.
The post Episode 19 – Rule 11 for Software Devices with Cyrille Michaud appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Is it the right moment to move to another position if you are in Quality and Regulatory affairs? Petra Ognjenovic from SciPro Global is helping us to decode the situation on the recruitment market. She will also provide us some tips to find the right candidate.
The post Episode 18 – QA RA Recruitment situation with Petra Ognjenovic appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
On this new Episode, Florent Guyon from Nexialist is sharing with us his anecdotes regarding unannounced audit. He will also talk to us about a Master Degree he proposes at the ISIFC Biomedical Engineering School
The post Episode 17 – Unannounced audit stories with Florent Guyon appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Sean Hamilton from War on Epilepsy is a Seanpreneur as he says on this episode. He is epileptic and this made him think that he can maybe create a Medical Device for people with the same condition. So he founded War On Epilepsy. Listen to his story which provides a great message.
The post Episode 16 – From Disease to a Medical Device with Sean Hamilton appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
On this second part of the podcast episode, Erik Vollebregt is continuing to tell us more stories on the background of the MDR and IVDR. We'll discuss about the differences between big and small companies and also the brexit, notified bodies and finally rule 11 for the classification of Software
The post Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Erik Vollebregt from Axon Lawyer is explaining to us what is the EU MDR and IVDR. This will be a 2 part episode with a lot of anecdotes. Erik is also the author of the blog MedicalDevicesLegal.com
The post Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Richard Young from Sensus group talk to us about the Brexit Situation. His company is located in the UK and is helping Medical Device manufacturers to overcome this situation. Brexit date is planned on March 29th, 2019 and for now there is no deal reached.
The post Episode 13 – Brexit Talk with Richard Young appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Marcelo Antunes from SQR Consulting is walking us through the process of Standard creation. You'll understand how you can participate to it and why it is so important. We will also discuss about the Elsmar Cove Forum that is a great source of support.
The post Episode 12 – How to create an ISO Standard with Marcelo Antunes appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Bill Stamm and Rafael Blanco from General Digital Software Services are helping us to understand Medical Device Software Validation. This process is becoming more and more important as the Healthcare business is transitioning to digitization.
The post Episode 11 – Medical Device Software Validation appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
On today’s show, I invited Angelina Hakim the CEO of Qunique which is an Agency helping customers on Regulatory projects and also provide some service as an auditor. She has […]
The post Episode 10 – Understand MDSAP with Angelina Hakim appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Show Notes This episode of the Medical Device made Easy Podcast is special as this is the first one I am doing with a guest. I have interviewed Ivan Perez […]
The post Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Learn one of the many methods to move your working area from Correction to Prevention with the ODIAC method. Don't try to find it on Google because I created it only for you. Learn how to solve issues before they come to your desk.
The post Episode 8 – From Correction to Prevention with ODIAC appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
KPIs means Key Performance Indicators. This is an important part of the Quality Management System of a company. This is not specific to Medical Devices but you have to have […]
The post Episode 7 – Make your KPIs Green again appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
On this episode of the Medical Device made Easy Podcast I will tell you what are the 6 Types of Medical Device Audits. I know that when you are talking about audit on your companies, there are some kind of Panic Mode. Or maybe you are more "Always Audit ready". So listen to learn more on audits.
The post Episode 6 – What are the 6 types of Medical Device Audits appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
2019 is here and as I read many media´s predictions for the medtech industry, I decided to also predicte myself what will be a trend. I will talk specifically about 2 axes which are Technologies and Regulations. Both are linked because as regulators we need to understand the technologies to be able to provide the right answer when we need to issue a regulation.
The post Episode 5 – Medtech Prediction 2019 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
UDI for Unique Device Identification. You will need to understand what is happening with the UDI to be able to implement it. So let´s learn first about the vocabulary.
The post Episode 4 – UDI for Unique Device Identification appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device made Easy Podcast Episode 3- On this episode I help you to define if your product is a Medical Device in Europe? I know it sounds basic but you´ll see that the new Medical Device Regulation MDR 2017/745 is changing the rules. So listen carefully.
The post Episode 3 – Is my Product a Medical Device in Europe? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The new EU Medical Device Regulation MDR 2017/745 will be in place by May 26th, 2020 but are you already aware of its content. Listen to this episode to know more.
I provide you some information the timeline for the application of the MDR and also the changes that happen. On the resources, I link to a blog post I created on this topic. And as a gift, I propose you to download an Alexa Skill to tell you how many days remains until the new Medical Device Regulation is live.
The post Episode 2 – New EU Medical Device Regulation MDR 2017/745 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Within this first episode of the Medical Device made Easy Podcast I am introducing myself and also this podcast. Don´t forget to subscribe to it so you can be notified when a new episode is released.
The post Episode 1 – Introduction to the Medical Device made Easy Podcast appeared first on Medical Device made Easy Podcast. Monir El Azzouzi