Device Advice by RQM+: Recent Episodes
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RQM+ industry-leading experts discuss regulatory and quality challenges medical device and diagnostic companies are facing.
RQM+ is the leading international provider of regulatory, quality, and compliance consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs, and committed to delivering high-value solutions that exceed expectations.
Visit RQMplus.com for more.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
In our latest clinical trials video, Manager of Safety Management Melanie Miller joins Jaishankar Kutty, Ph.D. to discuss the 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗮𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗮𝗻𝗱 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁 𝘀𝗮𝗳𝗲𝘁𝘆 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗶𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀.
Melanie covers:
📋 Key components of effective safety management
🔬 Pre-enrollment planning and study protocol design
📊 Importance of comprehensive safety management plan
💻 Leveraging digital-first mindsets and automation
🤝 Breaking down silos for improved communication
🎓 Ongoing training and education for all stakeholders
🔄 Continuous improvement in safety processes
𝗬𝗼𝘂'𝗹𝗹 𝗹𝗲𝗮𝗿𝗻 𝗮𝗯𝗼𝘂𝘁 𝘁𝗵𝗲 𝗹𝗮𝘁𝗲𝘀𝘁 𝘁𝗿𝗲𝗻𝗱𝘀 𝗶𝗻 𝘀𝗮𝗳𝗲𝘁𝘆 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁, 𝘁𝗼𝗼, 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴:
🤖 AI and machine learning in safety data analysis
📱 Digital health technologies for real-time patient reporting
👥 The roles of key players in the safety management process
There's a lot here! Effective safety management is crucial for maintaining data integrity, ensuring regulatory compliance, and most importantly, safeguarding patient well-being throughout the clinical trial process.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This presentation and panel was recorded 12 September 2024. We encourage you to download the slides presented during this session by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions!
We generally hold one RQM+ Live! panel discussion per month (in addition to occasional traditional webinars) and you can sign up for these events and more at the Knowledge Centerat RQMplus.com.
Thank you for tuning in. 🙏
The recently published Regulation (EU) 2024/1860 amends the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) by introducing some significant changes that will impact manufacturers and the entire MedTech industry.
One of the changes is the introduction of a requirement for manufacturers to inform national competent authorities in cases of supply chain interruptions, or the withdrawal from the market, of certain critical medical devices and IVDs.
Join our expert panel to explore the implications of these new obligations for manufacturers and learn actionable strategies to ensure compliance.
In this comprehensive discussion, our regulatory and quality experts will cover:
- Impact Assessment: An overview of the amendments, including changes to transition timelines for IVDR and the phased rollout of EUDAMED.
- Supply Chain Management: Insights into the new obligation for manufacturers to provide advanced notice of supply chain interruptions and strategies to ensure a robust and resilient supply chain.
- Industry Perspectives: An examination of feedback from industry stakeholders and how companies are preparing for these regulatory changes.
- Compliance Strategies: Guidance on meeting the new requirements, including implementation within your Quality Management System (QMS).
- Quality and Regulatory Support: How RQM+ can support your company with regulatory change assessments, EUDAMED data management, and the implementation of new supply chain notification processes.
By attending this event, you will gain a clear understanding of the amendments to MDR and IVDR and learn practical steps and strategies to achieve compliance. Register now to stay ahead of these critical regulatory changes and ensure the continued success of your products in the European market.
Panelists and moderator:
- Erik Vollebregt – Advocaat, Axon Science Based Lawyers
- Heike Moehlig-Zuttermeister – Global Director In-Vitro Diagnostics, TÜV SÜD
- Donielle Johnson – Global Regulatory Affairs Executive
- Ed Ball – Manager, Intelligence & Strategic Execution, RQM+
- Amie Smirthwaite, Ph.D. – Senior Vice President, Scientific Affairs, RQM+ (moderator)
Certificate of Participation available upon request for live attendees.
Who Should Attend: This panel discussion is ideal for regulatory affairs professionals, operations management, quality assurance professionals, production planning and supply chain managers, and MedTech manufacturers navigating the amended IVDR and MDR requirements.
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues as Christine Santagate, RAC chats with Dr. Anthony Grice, a leading chemist at Jordi Labs for over a decade!
Discover how "Ant" became our go-to 𝗖𝗦𝗜 𝗼𝗳 𝗖𝗵𝗲𝗺𝗶𝘀𝘁𝗿𝘆 🕵️♂️, solving complex problems with creativity. Ant shares:
✔️ His journey from the UK to becoming a polymer chemistry expert
✔️ The excitement of tackling diverse challenges in analytical chemistry
✔️ His experience with GPC and its applications in #medicaldevices
🔨 Some unconventional methods used to solve client problems (sledgehammer, anyone?)
✔️ Valuable advice for aspiring chemists and regulatory professionals
From deformulating golf balls to smashing solar panels, we hope Ant's interview inspires you and showcases the problem-solving ingenuity of RQM+/Jordi Labs staff.
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues this week, as Christine Santagate, RAC is joined by Lab Coordinator Craig Young of the Jordi Labs team.
👨🔬 Discover how Craig's diverse background in chemistry and project management led him to become an 𝗲𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗽𝗮𝗿𝘁 𝗼𝗳 𝗼𝘂𝗿 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀.
Craig shares:
✔️ His journey from WPI to Las Vegas and back to Mansfield
✔️ Experiences in biodiesel production and laboratory startups
✔️ How his "jack-of-all-trades" nature suits lab coordination
✔️ His role in implementing ClickUp for project management
✔️ Valuable advice for those entering the scientific industry
⚗️ We'll be continuing to highlight more Jordi Labs all-star team members in the coming weeks, so stay tuned.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues this week, as Christine Santagate, RAC is joined by Chemist II Michael Morales of the Jordi Labs team.
👨🔬 Discover how Michael's passion for chemistry led him to becoming a 𝘁𝗿𝘂𝗲 𝗲𝘅𝗽𝗲𝗿𝘁 𝗶𝗻 𝗴𝗮𝘀 𝗰𝗵𝗿𝗼𝗺𝗮𝘁𝗼𝗴𝗿𝗮𝗽𝗵𝘆.
Michael shares:
✔️ His journey through academia and into industry
✔️ The importance of perseverance in scientific research
✔️ His experience in tackling complex projects and method development
✔️ The rewards of mentoring and giving back to the scientific community
✔️ Valuable advice for those considering a career in chemistry
🔬 Check out the interview to learn from Michael's expertise and hopefully be inspired by his enthusiasm for analytical chemistry as well!
We plan to continue to highlight many more all-star employees from Jordi Labs in the coming weeks, so stay tuned.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
In our third and final clinical trials video focused on data management, Senior Director of Data Operations Noel Keegan returns to speak with Jaishankar Kutty, Ph.D. about the 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗿𝗼𝗹𝗲 𝗼𝗳 𝗖𝗥𝗢𝘀 𝗶𝗻 𝗱𝗮𝘁𝗮 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁.
Noel covers:
🤝 The importance of partnership between CROs and sponsors
🏆 Key performance and quality indicators across all trial phases
🔍 Independent quality review processes
📚 Leveraging standardized libraries and best practices
🎯 Tailoring services to meet specific sponsor needs
In the end, a CRO should act as an extension of the sponsor's team, providing expertise, accountability, and flexibility throughout the clinical trial process.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
👨🔬 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 short interview series continues this week, as Christine Santagate, RAC is joined by another member of the Jordi Labs team, Tommy Kumlin.
See how Tommy's background in chemistry and chemical engineering led him to become a jack-of-all-trades in analytical techniques. 🔬
Tommy shares:
✔️ His specialization in spectroscopy, microscopy, and thermal analysis
✔️ How he combines different techniques for comprehensive analysis
✔️ The satisfaction of instrument troubleshooting and maintenance
✔️ The importance of collaboration in a professional environment
✔️ Valuable advice for those entering the industry
Stay tuned as we plan to highlight additional Jordi Labs staff in the coming weeks! 🧫
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
🎉 The data management party continues!
Part 2 of our clinical trial data management series is here! Jaishankar Kutty, Ph.D. welcomes back Senior Director of Data Operations, Noel Keegan, to dive into the 𝗺𝗮𝗶𝗻𝘁𝗲𝗻𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗰𝗹𝗼𝘀𝗲𝗼𝘂𝘁 𝗽𝗵𝗮𝘀𝗲𝘀 of clinical trial data management.
In this discussion, Noel covers:
📊 Data validation activities post-database build
🔄 Managing external data from core labs, imaging, and safety
📈 Sharing validation progress with sponsors
🔒 Database lock timelines and best practices
📦 Archiving processes and considerations
💡 Key takeaway: Proactive data cleaning during the maintenance phase leads to a smoother, faster database lock!
🎬 Missed Part 1? Check out our previous video on the study setup phase of data management.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
🎉 It's a data management party – you in?
Our team had a ton of fun recording the newest video in our clinical trial video series and it's now available. Jaishankar Kutty, Ph.D. speaks with Senior Director of Data Operations, Noel Keegan, about 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗱𝗮𝘁𝗮 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗶𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀, specifically focusing on the study setup phase.
More particularly, Noel covers selecting appropriate electronic data capture systems, database setup timelines and risks, and considerations for data integration across platforms.
💾 𝘛𝘩𝘦 𝘯𝘦𝘹𝘵 𝘵𝘸𝘰 𝘷𝘪𝘥𝘦𝘰𝘴 𝘸𝘪𝘭𝘭 𝘢𝘭𝘴𝘰 𝘱𝘦𝘳𝘵𝘢𝘪𝘯 𝘵𝘰 𝘥𝘢𝘵𝘢 𝘮𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵, 𝘴𝘰 𝘬𝘦𝘦𝘱 𝘢𝘯 𝘦𝘺𝘦 𝘰𝘶𝘵.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 series of interviews with RQM+ employees returns today as Christine Santagate, RAC is joined by enthusiastic Jordi Labs Technical Program Lead Joshua Nott. 👋
🎥 Hear how Josh's journey from biochemistry to analytical chemistry led him to excel in customer service and technical problem solving. Josh also shares:
✔️ His transition into project management
✔️ How he builds rapport with clients
✔️ His experience teaching and mentoring students
✔️ Valuable advice for those starting their careers
We think you can learn from Josh's expertise and passion for analytical chemistry and hope you enjoy!
🔬 We'll be highlighting more Jordi Labs staff in the coming weeks.
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📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials.In these two videos (this is video 2) specific to site selection and monitoring, RQM+ experts reveal:
- Key considerations for selecting ideal clinical partners
- Red flags to watch out for during site selection
- Best practices for effective trial monitoring
- Risk-based approaches to remote and on-site monitoring
- Strategies for data cleaning and accountability
Featuring insights from:
- Margot Borgel - Director, IVD Global Regulatory Affairs
- Brandy Chittester - Senior Director, Clinical Operations
- Manali Patel - Clinical Research Associate
Whether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials.In these two videos (this is video 1) specific to site selection and monitoring, RQM+ experts reveal:
- Key considerations for selecting ideal clinical partners
- Red flags to watch out for during site selection
- Best practices for effective trial monitoring
- Risk-based approaches to remote and on-site monitoring
- Strategies for data cleaning and accountability
Featuring insights from:
- Margot Borgel - Director, IVD Global Regulatory Affairs
- Brandy Chittester - Senior Director, Clinical Operations
- Manali Patel - Clinical Research Associate
Whether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Centerat RQMplus.com.
Thank you for tuning in. 🙏
RQM+ welcomes Michelle Tarver, M.D., Ph.D., Acting CDRH Director and Deputy Center Director for Transformation, FDA, CDRH, to a presentation and panel discussion aimed at increasing awareness and understanding of equity in the medical device and IVD space.
Objectives:
- Regulatory Expectations
Examining health equity concerns, regulatory efforts to promote equity, and FDA requirements for enhancing diversity in clinical trials - Healthcare at Home
Exploring the "Home as a Healthcare Hub" initiative and its implications for health equity, including the challenges and opportunities of integrating healthcare services at home - Industry Perspectives
Providing insights from industry leaders on how medical device companies are addressing health equity, with a focus on real-world examples and action plans - Action Plans and Strategies
Sharing best practices for developing and implementing plans that assess diversity, explore risks, and identify actions to address health equity within medical device companies - Interactive Q&A
Offering an opportunity for participants to engage with experts, ask questions, and gain a deeper understanding of the topic
Panelists:
- Michelle Tarver, M.D., Ph.D. – Acting Director and Deputy Center Director for Transformation, FDA, CDRH
- Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovations, RQM+
- Jon Gimbel, Ph.D. – Vice President of Technical, RQM+
- Brandy Chittester – Senior Director, Clinical Operations, RQM+
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Our ongoing educational video series on 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀 covers three areas:
♟️ Strategy
🛠️ Execution
✅ Regulatory
Optimize your IVD clinical trials and watch our newest video in the series: 𝗧𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗜𝗩𝗗 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀.
Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D., is joined by Senior Director of Clinical Operations, Brandy Chittester, and Director of Business Development, Lauren Birch.
𝗪𝗮𝘁𝗰𝗵 𝗳𝗼𝗿 𝗲𝘅𝗽𝗲𝗿𝘁 𝗮𝗱𝘃𝗶𝗰𝗲 𝗼𝗻:
🔸 Outsourcing decisions and resource allocation
🔸 Critical pre-clinical testing considerations
🔸 Choosing the right clinical lab partner
🔸 Efficient execution strategies
🔸 Cost-saving tactics without compromising quality
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
🔄 We recently covered Site Selection In Clinical Trials and we're coming right back to share a new video on 𝗦𝗶𝘁𝗲 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴.
For 𝗦𝗶𝘁𝗲 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀, Jaishankar Kutty, Ph.D. is rejoined by Senior Director of Clinical Operations, Brandy Chittester, and also joined by Director of Clinical Operations, Martin Schulz.
𝗪𝗮𝘁𝗰𝗵 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻 𝗮𝗯𝗼𝘂𝘁:
◽ Balancing on-site and remote monitoring based on risk assessment
◾ Location-specific considerations in site management
◽ Strategies for maintaining audit readiness throughout the trial
◾ RQM+'s approach to efficient and effective site monitoring
In addition to general best practices, watching this will give you a feel for how our collective experience and lean structures at RQM+ enhance trial oversight while ensuring patient safety, data accuracy, and regulatory compliance.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
🆕 Our newest video: 𝗦𝗶𝘁𝗲 𝗦𝗲𝗹𝗲𝗰𝘁𝗶𝗼𝗻 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀.
Senior Director of Clinical Operations Brandy Chittester and Study Start-Up Associate Elicia Dellinger join Jaishankar Kutty, Ph.D. to explore the process.
𝗧𝗵𝗶𝘀 𝘃𝗶𝗱𝗲𝗼 𝗰𝗼𝘃𝗲𝗿𝘀:
- Key factors influencing site selection
- The step-by-step process of identifying and assessing potential sites
- Balancing communication between sponsors, CROs, and trial sites
- Strategies to mitigate enrollment risks
Anyone involved with clinical trial planning and execution will benefit from this one, with practical tips to enhance study success throughout.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
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💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This was recorded 18 July 2024. We encourage you to download the presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center or Events pages at RQMplus.com.
Thank you for tuning in. 🙏
The recently finalized EPA rule on ethylene oxide (EtO) emissions requires significant changes for sterilization facilities, potentially impacting manufacturers of sterile medical devices.
Listen to our expert panel to understand the implications of these new regulations and discover actionable strategies to explore potential mitigation activities.
In this comprehensive discussion, our experts will cover:
- Impact Assessment: A detailed analysis of the new EPA rule, including how it affects EtO sterilization facilities and manufacturers of sterile medical devices.
- Compliance Strategies: Guidance on softening EtO cycles to support the effort of reducing EtO emissions and ensuring compliance within the 2-3 year timeline.
- Alternative Sterilization Methods: An overview of viable alternatives such as Vaporized Hydrogen Peroxide (VHP), radiation, and more. We will discuss their pros and cons, regulatory requirements, and validation processes.
- Quality and Regulatory Support: Insights into design quality engineering, manufacturing quality engineering, regulatory change impact assessments, and more.
- Industry Perspectives: An examination of feedback from industry stakeholders and how companies are adapting to these changes.
Who Should Listen: This panel discussion is ideal for regulatory affairs professionals, quality engineers, manufacturing leaders, and medical device manufacturers who rely on EtO sterilization or are considering alternative methods.
By listening in, you will gain a clear understanding of the new EtO regulations, learn practical steps to mitigate for compliance-led changes at your sterilization facilities, and explore alternative sterilization methods to ensure your products remain safe and market-ready.
Please complete the form to watch the recording and download the slides.
Panelists:
- Jessica Dreyer – Senior Consultant, RQM+
- Gregory Murdock – Senior Manager, RQM+
- Jon Gimbel, Ph.D. – Vice President of Technical, RQM+ (moderator)
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💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 in the newest video in our clinical trials series.
𝗪𝗮𝘁𝗰𝗵 𝗳𝗼𝗿 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗼𝗻:
◽ Determining the regulatory pathway for your combination product
◾ Addressing regulators' primary concerns in submissions
◽ Overcoming clinical trial challenges unique to combination products
◾ Key learnings from real-world cases
Whether developing drug-device combinations, drug-eluting implants, or other innovative combination products, this video offers guidance to help avoid costly delays and regulatory pitfalls.
If you're interested in RQM+ helping you strategically approach combination product development and set your product up for regulatory success, let us know. 📞
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This conversation features a Q&A session with a CAPA-focused team from RQM+ and explores the unique value consultants bring to clients.
Our experienced team shares their top skills, dream projects, and what drives them to make a difference in the industry. From problem-solving strategies to personal inspirations, discover how these professionals are shaping the future of medical device quality and regulatory compliance.
Whether you're a professional simply interested in the field or a manufacturer interested in potentially leveraging consultant expertise, this conversation offers valuable perspectives.
Chapters
00:00 - Introduction to the Team
02:23 - The Difference Between Contractors and Consultants
05:13 - Leveraging Collective Knowledge for Client Success
07:36 - Top Skill Sets for Consulting Success
14:36 - Ideal Projects and Personal Goals
Panelists:
- Elaine M. Ruminski, MS - Senior Consultant
- Craig McIntire - Senior Consultant
- Makenzie Dorring - Consultant, CMDA
- Joe Commane - Consultant
- Scott Edwards - Managing Director
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📚 See on-demand content in our Knowledge Center.
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This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
Combination Device Clinical Trials: Strategy & Tactics
Join RQM+ experts Jaishankar Kutty, PhD and Chad Quistad as they unpack the complexities of combination device clinical trials in this comprehensive educational video.
Key topics covered:
- Definition and examples of combination devices
- Regulatory pathways in the US and EU
- Product development challenges unique to combination products
- Essential documentation for robust trial design
- Critical considerations for successful trial execution
Highlights include:
- The importance of cross-functional expertise in drug and device development
- Crucial pre-trial steps: usability studies, risk analysis, and early stability testing
- Strategies for overcoming common trial execution challenges
- Real-world case study demonstrating the value of proactive testing
Whether you're new to combination devices or looking to optimize your approach, this video offers valuable insights to enhance your clinical trial strategy.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
💡🏥 𝗨𝗻𝘃𝗲𝗶𝗹𝗶𝗻𝗴 𝘁𝗵𝗲 𝗦𝗲𝗰𝗿𝗲𝘁𝘀 𝗼𝗳 𝗦𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀
Part 2 of our key aspects of device trial design covers:
- Overcoming key barriers in trial design
- Balancing statistical significance with clinical relevance
- Strategies for faster enrollment and reduced dropouts
🎥 Cari Kniola, Guido Rieger, Rolf Hövelmann, and Jaishankar Kutty, Ph.D. share valuable insights to optimize your next clinical trial.
🔑 Key takeaway? 𝗘𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 𝗺𝗮𝘁𝘁𝗲𝗿𝘀. Learn how RQM+ leverages cross-functional expertise to design trials that deliver meaningful results.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
🤔 Struggling with patient recruitment for your medical device clinical studies?
Join RQM+ Clinical Trials COO David Novotny and THREAD CEO John Reites as they explore innovative hybrid study approaches to accelerate patient recruitment in MedTech research.
In this conversation, you'll learn how hybrid approaches can:
- Expand your recruitment reach beyond geographical limitations
- Boost patient engagement and retention rates
- Save time and resources on data collection
- Ultimately accelerate your product's path to market
David and John dive into specific study designs ideal for hybrid approaches, including pre- and post-market clinical studies and randomized controlled trials. They emphasize the importance of patient feedback and human-centered design in creating flexible, patient-centric protocols.
Key topics covered:00:00 Introduction and Overview03:16 Types of Study Designs for Hybrid Approaches09:07 Examples of Hybrid Approaches in Med Tech Studies16:05 Impact of Hybrid Approaches on Patient Recruitment28:26 Strategies for Working with Older Populations in Hybrid Studies
Don't miss this opportunity to transform your research process and make your studies more efficient and patient-friendly.
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📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
✏️ 𝗞𝗲𝘆 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 (𝟭/𝟮)
Cari Kniola, Guido Rieger, and Jaishankar Kutty, Ph.D. return for our educational clinical trial series, this time joined by Senior Manager of Biostatistics, Rolf Hövelmann.
This video covers...
𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 𝗙𝗮𝗰𝘁𝗼𝗿𝘀:
– Addressing and mitigating confounding factors, biases, and variations
– Ensuring treatment effects can be isolated
𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵:
– The importance of considering end goals for product and study
– Incorporating clinical expertise from the start
𝗦𝘁𝗮𝘁𝗶𝘀𝘁𝗶𝗰𝗮𝗹 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵:
– Effective trial design from a biostatistics perspective
– Traditional vs. adaptive trial designs
𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀:
– Balancing regulatory, reimbursement, and practical clinical needs
– Ensuring feasibility and practicality in trial execution
Look for the second video about trial design next week!
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn:
https://www.linkedin.com/company/rqmplus/
📺 The RQM+ YouTube channel:
https://youtu.be/tMMdyKrzoB8?si=OHO-kuO8RSQ6trUN
📧 For support with clinical trials, you can contact us directly here: https://www.rqmplus.com/book-consultation
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
🛡️ 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀
Senior Director of Clinical Operations Brandy Chittester and Senior Diretor of Project Management Cari Kniola join Jaishankar Kutty, Ph.D. to discuss...
𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗥𝗶𝘀𝗸 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀:
– Identifying and mitigating risks in trial design, budget, quality, timelines, site selection, enrollment dynamics, and safety
𝗞𝗲𝘆 𝗥𝗶𝘀𝗸𝘀 𝗧𝗼 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿:
– The responsibility of risk management
– The role of project managers and study teams
𝗘𝘅𝗲𝗰𝘂𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀:
– System-level and trial-level risks
– Effective risk management plans
𝗔𝘂𝗱𝗶𝘁 𝗥𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀:
– Ensuring site preparedness and audit readiness
– Continuous monitoring and risk control
In addition to our podcast, you can also see this content on LinkedIn and our YouTube channel.
💼 LinkedIn:
https://www.linkedin.com/feed/update/urn:li:ugcPost:7212080273813839872/?actorCompanyId=1464335
📺 The RQM+ YouTube channel:
https://youtu.be/tMMdyKrzoB8?si=OHO-kuO8RSQ6trUN
📧 For support with clinical trials, you can contact us directly here: https://www.rqmplus.com/contact
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💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
💰 𝗪𝗼𝘂𝗹𝗱 𝘆𝗼𝘂 𝗹𝗶𝗸𝗲 𝘁𝗼 𝗴𝗲𝘁 𝗿𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗱?
Securing regulatory approval is just the beginning. The newest video in our educational clinical trials series covers the intricacies of reimbursement strategy and its critical role in your product's success.
Daniel Lace, MD, CPE, FAAPL joins Jaishankar Kutty, Ph.D. to discuss:
𝗧𝗵𝗲 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝗰𝗲 𝗼𝗳 𝗦𝘁𝘂𝗱𝘆 𝗗𝗲𝘀𝗶𝗴𝗻:
– How study design impacts reimbursement potential
– The difference between inferiority and superiority studies
𝗥𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗺𝗲𝗻𝘁 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆:
– The necessity of a comprehensive reimbursement strategy from the prototype stage
– The impact of "me-too" devices versus innovative technologies on reimbursement
𝗠𝗮𝘀𝘁𝗲𝗿𝗶𝗻𝗴 𝘁𝗵𝗲 𝗥𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗺𝗲𝗻𝘁 𝗣𝗿𝗼𝗰𝗲𝘀𝘀:
– Key components: coding, payment, and coverage
– Challenges in reimbursement policy and how to address them
𝗣𝗹𝗮𝗻𝗻𝗶𝗻𝗴 𝗳𝗼𝗿 𝗦𝘂𝗰𝗰𝗲𝘀𝘀:
– The importance of planning early and thoroughly
– Strategies to avoid common pitfalls and ensure market access
Watch the full video and contact RQM+ to learn how you can optimize your reimbursement strategy and ensure your device's market success.
📧 Also, you can contact RQM+ directly here: https://www.rqmplus.com/book-consultation
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💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
🌍 Our educational video series on clinical trials continues today with 𝗧𝗮𝗰𝘁𝗶𝗰𝘀 𝗳𝗼𝗿 𝗚𝗹𝗼𝗯𝗮𝗹 𝗣𝗶𝘃𝗼𝘁𝗮𝗹 𝗦𝘁𝘂𝗱𝗶𝗲𝘀.
Senior Project Manager Guido Rieger joins VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D. to outline:
📋 𝗦𝘁𝗲𝗽𝘀 𝘁𝗼 𝗘𝘅𝗲𝗰𝘂𝘁𝗲 𝗮 𝗣𝗶𝘃𝗼𝘁𝗮𝗹 𝗧𝗿𝗶𝗮𝗹:
– Identifying key stakeholders
– Defining study endpoints and scope
– Budgeting and regulatory planning
🛠️ 𝗣𝗹𝗮𝗻𝗻𝗶𝗻𝗴 𝗮𝗻𝗱 𝗘𝘅𝗲𝗰𝘂𝘁𝗶𝗼𝗻:
– Study protocol development
– Regulatory submissions and ethics approvals
– Site and patient selection
🔍 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗡𝘂𝗮𝗻𝗰𝗲𝘀:
– Understanding local regulations
– Importance of local expertise
🚀 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗮𝗻𝗱 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀:
– Addressing patient recruitment issues
– Site selection and vendor coordination
– Risk management strategies
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💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
--- Send in a voice message: https://podcasters.spotify.com/pod/show/deviceadvice/message
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
🔍 Strategy for Global Pivotal Studies 🌍
Ever wondered what it takes to ensure the success of your clinical trials on a global scale? Our latest video in the 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 dives deep into the best practices for pivotal studies.
Join VP of Global Regulatory Affairs Jaishankar Kutty, Ph.D., along with industry veterans Brandy Chittester, Noel Keegan, and Guido Rieger, as they share their insights on:
🧠 Clearly defining endpoints
⚖️ Calculating an accurate sample size
🔍 Selecting an appropriate control group
📊 Using valid statistical methods
🤝 Collaborating with an experienced MedTech CRO
🌐 Global Study Considerations:
- Regulatory requirements
- Data quality and integrity
- Site and patient selection
- Reimbursement strategies
🧩 Data-Specific Considerations:
- Race and ethnicity data
- Data privacy (HIPAA, GDPR)
- Local regulatory compliance
🔍 Compliance and Reimbursement:
- Ensuring compliance with global standards
- Strategies for successful reimbursement
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📚 See on-demand content in our Knowledge Center.
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--- Send in a voice message: https://podcasters.spotify.com/pod/show/deviceadvice/message
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
❓ How do you effectively 𝗲𝘅𝗲𝗰𝘂𝘁𝗲 first-in-human clinical studies?
❓ What 𝘁𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝘀𝘁𝗲𝗽𝘀 ensure success?After our first two strategic videos, our educational video series on clinical trials continues with 𝗧𝗮𝗰𝘁𝗶𝗰𝘀 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀.
Frank Maier, Director of Project Management within RQM+ Clinical Trial Services, joins Jaishankar Kutty, Ph.D. to walkthrough tactical specifics of first-in-human (FIH) clinical investigations.
𝗪𝗮𝘁𝗰𝗵 𝗮𝗻𝗱 𝗹𝗲𝗮𝗿𝗻:
➡️ The steps for executing successful FIH studies
➡️ Key roles and responsibilities for sponsors and CROs
➡️ Importance of local expertise and compliance with changing regulations
➡️ Managing safety reporting and risk documentation
➡️ Strategic considerations for geographical site selection
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This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
❓ What are the CGMP principles and traceability requirements for 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? How do you manage device iterations and site selection effectively?
🎬 The second video in our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 – 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 (𝟮/𝟮) answers these questions. Once again, Jaishankar Kutty, Ph.D. is back with VP of Strategic Regulatory Affairs Sew-Wah Tay.
𝗪𝗮𝘁𝗰𝗵 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻:
📌 The importance of CGMP principles and full traceability for FIH devices
📌 Managing device iterations in a 10-15 patient FIH study
📌 Key considerations for site and physician selection across different geographies
We hope these strategies help you navigate the complexities of FIH studies and ensure success. RQM+ is here to help if you need it.
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This was recorded 6 June 2024. We encourage you to download the presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center or Events pages at RQMplus.com.
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Summary
The conversation discusses the proposed rule by the FDA for wound care devices and its potential impact on the industry. The panelists highlight the importance of wound care and the need for regulations to protect public health. They also discuss the concerns and criticisms surrounding the proposed rule, including the lack of scientific evidence supporting the need for reclassification. The panelists address questions about the criteria for classification, the impact on innovation and product availability, and the timeline for finalizing the rule. Overall, the conversation emphasizes the importance of balancing regulatory requirements with the need for innovation and patient care. The conversation focused on the proposed rule change by the FDA regarding wound care products and the potential impact on the industry. The participants discussed the concerns and challenges related to additional testing requirements, product classification changes, and labeling requirements. They also explored the potential opportunities for innovation in wound care. The conversation highlighted the need for collaboration between industry and the FDA to address the concerns and find a balance between patient safety and regulatory requirements.
Takeaways
- The proposed rule by the FDA for wound care devices has raised concerns and criticisms within the industry.
- There is a lack of scientific evidence supporting the need for reclassification and the proposed rule's impact on innovation and product availability.
- The FDA's focus on antimicrobial resistance is a key concern, but the panelists question the scientific rationale behind the proposed rule.
- The timeline for finalizing the rule is estimated to be one to two years, with potential legal challenges expected.
- Balancing regulatory requirements with the need for innovation and patient care is crucial in the wound care industry. The proposed rule change by the FDA regarding wound care products has raised concerns and challenges for the industry.
- Additional testing requirements are a major concern for manufacturers, as they can be costly and time-consuming.
- Product classification changes, particularly being bumped into the PMA category, can have significant implications for manufacturers.
- Collaboration between industry and the FDA is crucial to address concerns and find a balance between patient safety and regulatory requirements.
- There may be potential opportunities for innovation in wound care, particularly in the development of technologies that address antimicrobial resistance.
- It is important for manufacturers to stay informed, engage with the FDA, and be prepared for potential changes in regulations.
Chapters
00:00 Introduction and Overview
04:04 Why Wound Care Matters
17:36 Impact on Innovation and Product Availability
28:20 Wound Prevention and Patient Impact
31:09 Scientific Evidence and Concerns
34:47 Proposed Rule Changes and Societal Impact
35:46 Challenges of Showing AMR Clinically
37:43 Pretextual Changes and Labeling
39:49 Exploring Other Technologies for AMR Concerns
42:05 Concerns and Poll Results
51:51 Working with FDA and Closing
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This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.
❓ What are the objectives and benefits of conducting 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? What are the key considerations and best practices for manufacturers?
We have answers.
🏥 Here's the first video in our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 – 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 (𝟭/𝟮). Join VP of Strategic Regulatory Affairs Sew-Wah Tay and VP of Global Regulatory Affairs Jaishankar Kutty, Ph.D. as they discuss crucial strategic considerations for first-in-human (FIH) studies.
𝗪𝗮𝘁𝗰𝗵 𝗮𝗻𝗱 𝘆𝗼𝘂 𝘄𝗶𝗹𝗹 𝗹𝗲𝗮𝗿𝗻:
📎 The objectives and benefits of conducting FIH studies
📎 Key considerations and best practices for manufacturers
📎 How to navigate early-stage challenges effectively
Don't miss this strategic guidance that will help you streamline your FIH study process and make informed decisions. Watch now... and stay tuned for part two!
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🎓 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝗼𝘂𝗿 𝗻𝗲𝘄 𝗲𝗱𝘂𝗰𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝘃𝗶𝗱𝗲𝗼 𝘀𝗲𝗿𝗶𝗲𝘀 𝗼𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀.
Our VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D., welcomes you to a free series designed to share our wealth of knowledge and best practices in clinical trial strategy, execution, and regulatory expertise.
𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗼𝗳 𝘁𝗵𝗶𝘀 𝘀𝗲𝗿𝗶𝗲𝘀:
✨ In-depth insights from industry experts
🛠️ Practical tips and best practices
📄 Comprehensive and interactive learning opportunities, including technical briefs, white papers, webinars, and RQM+ Live! panel discussions
𝗨𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝘃𝗶𝗱𝗲𝗼𝘀 𝘄𝗶𝗹𝗹 𝗰𝗼𝘃𝗲𝗿 𝘁𝗵𝗿𝗲𝗲 𝗸𝗲𝘆 𝗮𝗿𝗲𝗮𝘀:
📊 Clinical trial strategy
⚙️ Clinical trial execution
📜 Regulatory expertise in clinical trials
𝗥𝗤𝗠+ 𝗶𝘀 𝗮 𝗹𝗲𝗮𝗱𝗶𝗻𝗴 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢, with a legacy spanning 40 years in the industry, and we plan to show you many of the reasons why through this content. Stay tuned to our LinkedIn page and podcast in the coming months and feel free to share the news with your networks! We'll be providing as much value as we can. 📚
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
"Encouraging and driving a strong culture of quality allows a company to effectively manage the details in a collaborative way."
Scott Edwards, Managing Director at RQM+, shares his extensive industry experience and personal journey in our latest 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview.
𝗦𝗼𝗺𝗲 𝗼𝗳 𝗦𝗰𝗼𝘁𝘁'𝘀 𝗔𝗱𝘃𝗶𝗰𝗲?
🔘 Establishing solid relationships and fostering a strong culture of quality are crucial in the medical device industry.
🔘 Understanding the FDA's perspective and navigating corporate politics are important for success.
🔘 Listening to and learning from experienced mentors is extremely important for newcomers in the field.
🔘 Before making changes, it is essential to understand the existing processes and the impact of decisions on patients.
We hope you enjoy this interview with Scott hosted by VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D.!
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This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com.
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Summary
In this conversation, panelists discuss the crucial role of Notified Bodies in the EU regulatory environment for IVDs and medical devices. They highlight the challenges faced by manufacturers due to changing regulations and the consultative nature of Notified Bodies, emphasizing the differences between the decentralized EU regulatory structure and the US system.
The panelists provide updates on the extended transition timelines for IVDR implementation and introduce the concept of structured dialogue as a means to address uncertainties and provide clarity for manufacturers. They also delve into the importance of governance for Notified Bodies in assessing regulatory changes and ensuring compliance.
The expertise and qualifications of Notified Body personnel are emphasized, with a focus on their technical background, skills, and attitude. Manufacturers are encouraged to provide clear and comprehensive technical documentation to facilitate effective interactions with Notified Bodies.
The role of Team NB in harmonizing processes among Notified Bodies is discussed, along with the potential limitations of relying solely on MedTech Europe guidance, which represents industry perspectives and may not fully align with regulatory requirements.
Throughout the conversation, the panelists share their backgrounds and expertise in the IVD and medical device regulatory field, providing valuable insights into the complex landscape of EU regulations and the critical role played by Notified Bodies in ensuring compliance and market access for manufacturers.
Takeaways
- Notified Bodies are essential for ensuring compliance and market access for IVDs and medical devices in the EU.
- Manufacturers must navigate a challenging and evolving regulatory landscape, working closely with Notified Bodies to address uncertainties and maintain compliance.
- Clear technical documentation, expertise, and harmonized processes are key factors in fostering successful interactions between manufacturers and Notified Bodies.
- While industry guidance can be helpful, manufacturers must ultimately ensure their compliance with the official regulatory requirements.
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𝗡𝗘𝗪𝗦 → FDA releases final rule on Laboratory-Developed Tests (LDTs) 🚨
RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including:
✅ The 4-year phase-in timeline for compliance
✅ Expanded enforcement discretion for certain LDTs
✅ Grandfathering clause for currently marketed LDTs
Watch now to learn how this rule impacts your business and what steps you need to take to ensure compliance.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🔬 Hot on the heels of Jordi Labs' groundbreaking new publication support for simulated use testing of blood-contacting medical devices, we're thrilled to showcase one of Jordi's shining stars in our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 series: Meet Samantha Howard, Study Director! 🌟
As an influential voice within Jordi Labs, an RQM+ company, Samantha's deep knowledge and exceptional communication skills have made her a go-to resource for clients seeking solutions to complex problems. Her work directly supports Jordi's mission to 𝗺𝗮𝗸𝗲 𝗰𝗵𝗲𝗺𝗶𝗰𝗮𝗹 𝗰𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝗮𝘀 𝗮𝗰𝗰𝘂𝗿𝗮𝘁𝗲 𝗮𝗻𝗱 𝗰𝗼𝗻𝘃𝗲𝗻𝗶𝗲𝗻𝘁 𝗳𝗼𝗿 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝘀 𝗮𝘀 𝗽𝗼𝘀𝘀𝗶𝗯𝗹𝗲.
With nearly 7 years of experience at Jordi Labs, Samantha has grown from chemist to project manager to study director, honing her strategic skills along the way. Her thoughtful, focused, and analytical approach brings a 𝗵𝘂𝗺𝗮𝗻 𝗰𝗼𝗻𝗻𝗲𝗰𝘁𝗶𝗼𝗻 to highly technical programs.
🧪📚 In this interview, Samantha shares her passion for analytical chemistry, her dedication to continuous learning, and her advice for those entering the industry. She emphasizes the importance of asking questions, learning from experienced colleagues, and embracing growth opportunities.
We hope you'll join us in celebrating Samantha's achievements and the 𝗽𝗼𝘀𝗶𝘁𝗶𝘃𝗲 𝗶𝗺𝗽𝗮𝗰𝘁 she makes on our clients' success! We think this is a great interview to watch for industry veterans and newbies alike. Watch the full interview to learn more about Samantha.
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In this special bonus clip from our Excellence Spotlight series, Sr. Director of Data Operations (Clinical Trials) Noel Keegan takes a deep dive into clinical data management.
From the transition to electronic systems to the exciting potential of AI, Noel reflects on the evolution he's witnessed over his 16+ year career. He breaks down the key aspects of data management across the study lifecycle:
🏁 Study Start-Up: Collaborating with cross-functional teams to build user-friendly, robust databases with carefully considered edit checks.
🏃♂️ Ongoing Maintenance: Proactively cleaning data, generating oversight listings, and locking data progressively to ensure smooth deliverables later on.
🎯 Database Lock: Achieving efficiencies that enable rapid timelines from last patient visit to lock.
Noel also discusses key differences in data management approaches between medical devices, IVDs, and pharma. While the core principles of data reliability and integrity are universal, he notes the generally "lighter touch" in MedTech vs. the extensive external data reconciliation often required in pharma.
This discussion is a great example of the critical thinking required to deliver top-tier data management services customized to each client's unique needs. This is what we do at RQM+. Thank you to Noel for this look at what goes on behind the curtain to ensure the success of the clinical trials we support!
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While we believe you will find Nancy's story and advice inspiring without visuals, we encourage you to watch the video version containing a brief presentation on the RQM+ website here.
In this heartfelt and insightful video presentation, now available on our blog, Nancy Morrison, RAC shares her journey and the lessons she's learned along the way. Nancy is as highly a respected professional as you'll 𝘦𝘷𝘦𝘳 find in regulatory affairs and as she embarks on her well-deserved retirement, she generously takes the time to impart her wisdom and provide guidance to those aspiring to build a successful career in regulatory affairs. 👩🏫
In her presentation, which features a brief introduction from RQM+ VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D., Nancy discusses the importance of embracing challenges, building credibility, and fostering positive relationships with colleagues and regulatory bodies. She emphasizes the significance of understanding the "why" behind regulations and encourages others to seek new opportunities and innovative approaches.
She also shares the story of her son Matthew, who relies on numerous medical devices daily. This personal connection underscores the crucial role regulatory affairs professionals play in ensuring the safety and effectiveness of products that directly impact patients' lives. 🦼
We believe Nancy's insights and personal story will inspire everyone, but especially those in RA/QA. Her words can help guide your own career path and help you to navigate the complexities of the regulated industry with confidence and purpose.
And from RQM+, Nancy... we couldn't possibly put into words how much we appreciate you and the positive contributions you've made to our clients over the years. You've changed the MedTech industry for the better in immeasurable ways. Thank you. 🙏
With that said, she's not done yet! Join Nancy on Tuesday, 16 April for her live webinar: Aligning Your QMS with the FDA's QMSR Updates. See this link for more information and to register (or watch on demand after 16 April).
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This show was recorded 28 March 2024. We encourage you to download the presentation given in the first portion of this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com.
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Summary
The conversation in this part focuses on the importance of quality systems and compliance in preventing negative impacts on customers, patients, and reputation. The panelists discuss the history and evolution of FDA regulations for medical devices, the potential consequences of not following these regulations, and the need for a strong quality culture within organizations. They also highlight the significance of effective communication, continuous improvement, and proactive remediation activities in staying ahead of compliance risks and device recalls. The conversation highlights the importance of making quick decisions in the medical device industry, especially when it comes to recalls and addressing patient risk. It is crucial to have a concise committee with the right players and a designated decision-maker. Organizations should err on the side of being conservative and prioritize patient safety over financial concerns. Complaint handling and CAPA (Corrective and Preventive Actions) are key components of a robust quality management system. It is important to have a culture of quality that starts from the top and encourages open communication and collaboration. Internal audits and continuous inspection readiness are essential for maintaining compliance and reducing the cost of non-quality. Lack of leadership accountability is identified as a significant barrier to creating a culture of quality.
Takeaways
- Quality systems and compliance are crucial in preventing negative impacts on customers, patients, and reputation.
- Understanding the history and evolution of FDA regulations for medical devices provides context for the importance of compliance.
- Non-compliance with FDA regulations can lead to various consequences, including warning letters, product recalls, import detention, and civil money penalties.
- A strong quality culture within an organization is essential for maintaining compliance and preventing compliance issues.
- Effective communication, continuous improvement, and proactive remediation activities are key in staying ahead of compliance risks and device recalls. Quick decisions need to be made in the medical device industry, and a concise committee with the right players and a designated decision-maker is essential.
- Organizations should prioritize patient safety over financial concerns and err on the side of being conservative when it comes to recalls and addressing patient risk.
- Complaint handling and CAPA are crucial components of a robust quality management system.
- A culture of quality that starts from the top and encourages open communication and collaboration is necessary for maintaining high-quality products.
- Internal audits and continuous inspection readiness are important for staying compliant and reducing the cost of non-quality.
- Lack of leadership accountability is a significant barrier to creating a culture of quality.
Chapters
00:00 Introduction and Overview
04:12 Evolution of FDA Quality System Regulation
07:17 Consequences of Non-Compliance
12:29 FDA 483 Citation Data
29:10 Making Decisions and Recalls
32:31 CAPA and Complaint Handling 39:22
Creating a Culture of Quality
45:01 Takeaways and Conclusion
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Our Excellence Spotlight interview series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. These employees are committed to technical excellence and make significant positive contributions to our clients' success.
In our newest interview, we're thrilled to showcase Vice President of Strategic Regulatory Affairs, Dr. Sew-Wah Tay. It was tough to share just a single quote from this interview! Jaishankar Kutty, Ph.D. definitely helped bring out the best in Sew-Wah.
With a rich background in science and engineering, Sew-Wah's had an incredible career. She's a master of interdisciplinary innovation and can skillfully navigate regulations and clinical trials... all with a commitment to teamwork.
She also refuses to give up in the face of seemingly impossible challenges. We could share some quotes from her around that but we encourage you to watch the interview to hear them right from Sew-Wah. 🎧
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RQM+ Vice President of Global Regulatory Affairs (and former BSI), Jaishankar Kutty, Ph.D., discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip.
In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilitate the review process. 📖
Highlights:
- Notified body reviewers play a crucial role in the review process of clinical evaluation reports (CERs) under the MDR.
- Manufacturers should appreciate the challenges faced by notified bodies and provide clear and comprehensive information in their CERs.
- The review process is time-constrained, and reviewers rely on sampling and calibration to navigate through the documentation.
- Different reviewers may generate different questions based on their background and experience, but the goal is to enable an effective review of the CER.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 With a fascinating career spanning drug development with GSK to addressing ESPN's water issues, RQM+ / Jordi Labs Senior Study Director Adam Eason's journey has shown his willingness to embrace the unknown and leverage seemingly every experience when solving complex scientific problems.
🔬 His diverse experience includes drug development, environmental chemistry, and polymer chemistry testing. In the interview, you'll hear just how important 𝗰𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻 and 𝗽𝗿𝗼𝗯𝗹𝗲𝗺-𝘀𝗼𝗹𝘃𝗶𝗻𝗴 𝘀𝗸𝗶𝗹𝗹𝘀 are in this role as Senior Study Director.
👥 Sharing achievements with this team? 𝗧𝗵𝗮𝘁'𝘀 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁, 𝘁𝗼𝗼, and leads to a positive work environment and efficient projects.
We hope you'll join us in celebrating Adam's impactful contributions to RQM+ / Jordi Labs clients and the inspiration he offers his teammates! 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Our newest Excellence Spotlight interview is with Noel Keegan, a central figure in RQM+ clinical trial services. Noel is Sr. Director of Data Operations and has expertise that bridges gaps between data management, clinical operations, and regulatory compliance. His forward-thinking approach has elevated our clinical trial methodologies and consistently ensured the success and integrity of our trials.
Starting with a pharmacology degree and skills as an excellent project manager, Noel's career is like many at RQM+: connecting scientific rigor with operational excellence.
🤝 A Belief in Partnership: Noel thrives on building empowered teams and fostering transparent, collaborative relationships with clients. His approach is about being "proactively reactive," anticipating needs, and customizing solutions to fit each unique project.
🔥 Inspiring to Others: Beyond the accolades, Noel finds joy in mentoring, inspiring his teams, and contributing to groundbreaking medical advancements. He knows when his team shines, he does as well.
🌱 Advice for the Future: To those embarking on their journey in clinical research or data management, Noel emphasizes flexibility, open-mindedness, and courage to use one's unique skills to innovate and improve project delivery.
Noel has contributed a significant amount to clinical research and data management for our clients at RQM+ and it's an honor for us to celebrate that in this interview. 🙏
Thank you to Jaishankar Kutty, Ph.D. for conducting the interview as well!
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🔬 Kaitlin Lerner is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most brilliant minds on the RQM+ Lab Services / Jordi Labs team.
In this week's Excellence Spotlight interview, she shares her fascinating journey with Lab Services Chief of Staff, Christine Santagate, RAC (welcome to the Excellence Spotlight, Christine 👋).
🎓 With roots deeply planted in analytical and physical chemistry from Boston College and a Master's from Illinois Institute of Technology, Kaitlin's dedication to mastering the science behind medical devices and pharmaceuticals – paired with her passion for improving lab operations – has led to truly transformative (no exaggeration) innovations at RQM+ / Jordi Labs.
Kaitlin is an enormous reason RQM+ / Jordi Labs is often referred to as the ‘Gold Standard’ in extractable-leachable testing and is held in extremely high regard by the FDA.
🧽 Her advice to aspiring scientists? Be a sponge. Absorb knowledge, engage in diverse projects, and never shy away from asking why. This curiosity and commitment to continuous learning is why Kaitlin is at the forefront of her field today.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Yesterday, we published a clip of RQM+ Senior Consultant Anastassia Young, MS discussing our recent conversation with the FDA related to Adverse Event (AE) Reporting. Today, it's time to shine the spotlight on her and only her in our newest Excellence Spotlight. 🔦
A quick glance at what Anastassia brings to RQM+ and our clients:
🔍 Technical Savvy and Storytelling: Her impressive background in science and medicine, enriched by her experiences from Kyrgyzstan to New York University, empowers her to provide incredible value to RQM+ clients and regulatory bodies alike.
💡 From Clinical Medicine to Regulatory Expertise: Transitioning from a prospective medical career to leading in regulatory affairs, she uses her clinical insights to drive innovation and provide cutting-edge solutions for our clients.
🤝 Relationships and Empowerment: Rooted in the importance of relationships, Anastassia fosters a culture of success and confidence within her team. Collaboration and empowerment are words you'll hear often at RQM+, and Anastassia is no exception.
Please feel free to comment and join us in celebrating Anastassia's wonderful story and the meaningful impact she has on RQM+, our clients, and the wider MedTech community. 🙏
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Are you navigating adverse event (AE) reporting in post-market clinical follow-up (PMCF) studies?
In a recent discussion with the FDA, we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden. This collaboration between RQM+ and the FDA paves the way for a more efficient process, allowing for the submission of a single summary report for AE data collected in PMCF studies.
🍿 You'll want to watch for...
Valuable FDA Insights: Learn about exemptions and variants for AE reporting.
Efficient Data Collection: Discover how surveying healthcare providers and analyzing anonymous patient data leads to meaningful AE data collection.
FDA Collaboration: Understand the FDA's approach to determining reporting requirements and encouraging the proactive collection of real-world data.
Streamlined Reporting Process: A single summary report could replace multiple individual reports, easing the burden on manufacturers.
From exemptions and variances to collaborative reporting efforts, this discussion between Anastassia Young, MS and Jaishankar Kutty, Ph.D. is packed with valuable information that can help your company navigate the AE reporting more effectively.
🕒 Jump to a specific segment in the video:
00:00 Introduction and Background
01:00 FDA Discussion on Adverse Event Reporting
03:05 Exemptions and Variants for Reporting
04:26 Collaboration with FDA for Reporting
05:14 Streamlining Reporting Process
06:11 Summary and Blog Announcement
07:06 FDA's Mission and Collaboration
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This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com.
Thank you for tuning in. 🙏
Summary
The panelists discuss the requirements for claiming equivalence under the MDR and provide examples of devices that are impacted. They also address actionable steps and next steps for manufacturers. The discussion covers the importance of PMCF studies and the evidence levels required. The panelists also clarify the requirements for claiming equivalence to devices with expired CE marks and within product families. The conversation covers topics such as technical equivalence and benchtop testing data, PMCF studies and registries, changes in PMCF under MDR, the difference between level 3 data producing registries and level 4 data producing retrospective studies, the purposes of registries and surveys, accessing data without a contract, the need for sufficient clinical evidence, acceptance of the new interpretation by notified bodies, reviewers' perspective on equivalence, the timing of the guidance, and action items for manufacturers.
Takeaways
- Manufacturers can claim equivalence with other devices to leverage their clinical data, even for new devices.
- The MDCG 2023-7 guidance clarifies the requirements for claiming equivalence under the MDR.
- PMCF studies must generate level four data for class three and implantable devices.
- Claiming equivalence to devices with expired CE marks can be high-risk and should be approached with caution.
- Claiming equivalence within product families requires careful consideration of the differences in materials and clinical indications. Technical equivalence requires connecting a story with appropriate data.
- PMCF studies have changed under MDR, with the nomenclature shifting from proactive and reactive to general and specific activities.
- Registries provide continuous data over the lifetime of a device, while surveys offer a snapshot in time.
- Manufacturers can access data without a contract by relying on publicly available information, reverse engineering, or comparative testing.
- The need for sufficient clinical evidence and the requirement to demonstrate clinical, technical, and biological equivalence remain unchanged.
- Notified bodies are accepting the new interpretation of equivalence.
- Manufacturers should revisit their product portfolios and consider leveraging the new guidance.
- Understanding the nuances of the guidance document is crucial.
- Manufacturers should have discussions with their notified bodies to align on the application of the guidance.
- Consider salvaging indications for devices that have been narrowed and explore the possibility of conducting PMCF studies.
- Read the guidance document thoroughly and seek expert assistance if needed.
Chapters
- 00:00 Introduction and Agenda
- 01:06 Introduction to RQM Plus
- 01:31 Introduction to Panelists
- 10:09 Examples of Devices Impacted
- 21:26 PMCF Studies and Evidence Levels
- 25:03 Claiming Equivalence to Devices with Expired CE Marks
- 28:50 Claiming Equivalence to Multiple Manufacturers and Devices
- 32:18 Claiming Equivalence within Product Families
- 35:00 Technical Equivalence and Benchtop Testing Data
- 35:30 PMCF Studies and Registries
- 36:36 Changes in PMCF under MDR
- 37:32 Level 3 Data Producing Registries vs Level 4 Data Producing Retrospective Studies
- 39:04 Different Purposes of Registries and Surveys
- 40:29 Accessing Data without a Contract
- 43:05 What Hasn't Changed: Need for Sufficient Clinical Evidence
- 44:20 Acceptance of the New Interpretation by Notified Bodies
- 46:17 Reviewers' Perspective on Equivalence
- 52:28 Timing of the Guidance and Revisiting Product Portfolio
- 55:05 Action Items for Manufacturers
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🌌 Meet the supremely talented Song Seto, PhD, RAC in our latest Excellence Spotlight interview. Song is a Principal in our RA/QA practice.
With a rich background from University of California, Berkeley and Georgia Institute of Technology, as well as experience as a lead reviewer at the FDA, Song's journey is impressive... and this is exactly the experience and capability she brings to RQM+ clients.
📜 Regulatory Expertise: Song brings exceptional regulatory knowledge to the table, navigating the landscape of EU MDR submissions with precision. Her work is instrumental in guiding our clients through the intricate processes, ensuring compliance.
✍️ Masterful Technical Writer: Whether it's grant writing for space science or crafting medical device documentation, Song's ability to convey complex ideas with clarity is superb.
🧠 Mathematical Prowess: Song's interest in mathematics isn't just a hobby—it's a tool in her arsenal, helping her to creatively solve regulatory challenges with a unique analytical rigor.
🌟 Impact on RQM+ Clients: Song's contributions have been pivotal. From leading successful EU MDR submissions to offering strategic regulatory advice/consulting, she has continually elevated our client's projects.
Watch the interview and discover more about how Song's blend of scientific rigor, regulatory expertise, and passion for continuous learning make her a cornerstone of RQM+'s success.
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Summary
This discussion provides a high-level overview of the current state of artificial intelligence (AI) in in vitro diagnostics (IVDs).
The conversation between Director of IVD Intelligence and Innovation, Margot Borgel, and Principal Regulatory Scientist, Bethany Chung, Ph.D., RAC, covers several aspects of AI in IVDs, including its use in diagnosis and predictive algorithms, aiding in the diagnostic workflow, supporting performance testing, and assisting in regulatory efforts. The importance of considering the global view of AI – including public opinion, diversity, privacy, and cybersecurity – is also highlighted.
Takeaways
- AI is rapidly growing in the field of IVDs, with a significant increase in the number of AI-based medical devices being approved by regulatory authorities.
- AI is used in IVDs for diagnosis and predictive algorithms, aiding in the diagnostic workflow, supporting performance testing, and assisting in regulatory efforts.
- Regulatory workflows can be enhanced with AI, including software that aids in literature reviews, aligns regulatory documents, and assists with PMS analysis.
- Considering the global view of AI in IVDs is crucial, including addressing bias, ensuring diversity in training data, complying with privacy laws, and prioritizing cybersecurity.
Chapters (Approximate)
- 00:00 Introduction and Current State of AI in IVDs
- 05:20 AI in IVDs: Diagnosis and Predictive Algorithms
- 12:18 AI in IVDs: Aiding in the Diagnostic Workflow
- 15:48 AI in IVDs: Supporting Performance Testing
- 24:45 AI in IVDs: Supporting Regulatory Efforts
- 30:23 Global View of AI in IVDs
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🔬 Meet RQM+ Director of Biological Evaluation Consulting, Taryn Meade, in our latest Excellence Spotlight interview!
Jaishankar Kutty, Ph.D. describes her as "elegant, talented, quietly confident, and always understated," but we're not going to be understated here! It's time to deservedly shine the spotlight on Taryn and what she brings to RQM+ and our lab clients.
With a decade in medical device and pharmaceutical development, Taryn stands out as an undeniable expert in biological safety evaluation. Taryn comes to RQM+ from the esteemed Jordi Labs, who was acquired by RQM+ in 2022.
Some highlights 🔦
🥼 Lab Expertise: Taryn's unparalleled skill set in the laboratory is matched only by her deep understanding of bioethics and ISO 10993 standards. Her critical role in guiding RQM+ clients through challenging regulatory landscapes is nothing short of impressive.
🧪 Critical Thinking: With a foundation in chemistry and a knack for logical analysis, Taryn anticipates challenges and produces strategic solutions that ensure product safety and compliance, setting her apart in the biocompatibility field.
📖 A Passion for Learning: Taryn's career trajectory is marked by a relentless pursuit of knowledge, tackling new challenges and expanding her expertise beyond her comfort zone. Learn more in the interview!
🛡️ Bioethical Strength: Above all, Taryn's unwavering commitment to patient safety and ethical compliance underscores her role as an admirable leader. Taryn's exceptional lab prowess not only elevate our lab services team and capabilities, but ensure RQM+ remains at the forefront of delivering industry-leading safety evaluations for our clients.
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We deliver full lifecycle materials science and chemical characterization capabilities. RQM+ / Jordi Labs is often referred to as the ‘Gold Standard’ in extractable-leachable testing and is held in extremely high regard by the FDA. Our expertise spans from conceptual bench top testing and prototyping through design verification and validation, preclinical testing, and post-market lifecycle management.
Services include:
- Material and Chemical Characterization
- Toxicological Risk Assessments
- Extractable-leachable Analysis
- Biological Evaluations
- Polymer Investigation
- Expert Scientific Consulting Across the Development Lifecycle and Post-Market Phase
Learn more and book a consultation with us here.
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📢 Hear Jaishankar Kutty, Ph.D.'s four-minute summary on MDCG 2023-7 and how you can benefit from attending next week's RQM+ Live! panel discussion: New Clinical Evidence Pathways for Legacy and New Devices.
🎟️ RSVP for the 22 February event here.
Why are we talking about this?
To address and clarify potential misinterpretations of Article 61, Items 4, 5, and 6, highlighted by the formation of an MDCG task force.
End goal of next week's panel?
To answer audience questions and provide a robust discussion that leads to a renewed understanding of equivalence in the EU for everyone who attends.
🔗 RSVP and we'll email connection details. We'll be sharing exclusive content with those who sign up.
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🎟️ RSVP for the 22 Feb. panel and get exclusive content.
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🏥 In connection with the FDA’s recent approval of Edwards Lifesciences’ transcatheter tricuspid valve replacement device, here is some commentary from RQM+ Vice President of Intelligence & Innovation, Jaishankar Kutty, Ph.D., about the importance of the benefit-risk story within the target patient population under the aegis of the state of the art and standard of care, in justifying the quantity of clinical data.
Jai also discusses certain aspects of uncertainty that will face other followers in this technology space. Finally, there is time spent on some critical post-market areas that regulators could be focusing on for this device, and they they almost certainly will be focusing on for other devices to follow (perhaps in the pre-market phase). 📊
🕒 Timestamps if you'd like to jump ahead:
00:00 Introduction and Basis of Approval
03:22 Clinical Data and Outcomes
06:14 Regulatory Uncertainties for Device Manufacturers
10:33 Post-Market Areas of Focus for Regulators
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
From bioengineering student at the University of Pittsburgh to PMCF study leader, meet Garrett Jeffries, PhD in our newest Excellence Spotlight interview.
A snapshot of Garrett’s background and impact to RQM+ clients:
🔬 Bioengineering Brilliance: Garrett has built a career that blends engineering expertise with clinical savvy. His work has spanned the full spectrum of device development, and notably embodies a holistic approach to innovation in the pulmonary space.
📊 Clinical Evaluation Know-How: As a pivotal figure in navigating EU MDR, Garrett has sharp insight when it comes to clinical evaluations and post-market data generation for legacy devices. A theme across many RQM+ consultants: His knack for transforming complex regulatory challenges into straightforward solutions has made him an indispensable asset to manufacturers facing the demands of EU MDR compliance.
📝 Exceptional Analytical Writing Skills: Garrett’s transition from the lab to leading PMCF studies illustrates his ability to critically analyze data and articulate findings. His writings not only meet standards, but exceed them when it comes to clinical and post-market documentation, setting a high benchmark for quality.
Garrett's journey at RQM+ underscores the value of interdisciplinary expertise in regulatory. His work positions our clients to succeed in the near- and long-term as industry requirements evolve. His ongoing contributions continue to set the standard for clinical and post-market excellence at RQM+.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
📜 Elizabeth Starling went from law school aspirations to becoming a force in regulatory affairs and clinical research as a Senior Consultant at RQM+. Hear her story in our newest Excellence Spotlight interview.
Just a snippet of what sets Elizabeth apart:
🧠 Deep Regulatory Knowledge: With a background that combines legal savvy with regulatory expertise, Elizabeth can dissect the most intricate compliance challenges and offer strategic solutions that drive client success.
✍️ Exceptional Writing Ability: Elizabeth has a knack for translating complex regulatory requirements into compelling narratives that not only meet compliance standards, but also strategically position products for market success. This is key for clarifying the path to approval for cutting-edge medical technologies.
🔝 Setting the Standard: Elizabeth leads by example and her teams complete projects at the highest level of quality. Her leadership directly contributes to RQM+'s reputation for delivering excellence in RA/QA consulting.
Elizabeth’s story is definitely a reminder of how versatility and a willingness to embrace change can lead to unexpected and rewarding paths. Her contributions to RQM+ our clients have not just enhanced our capabilities, but have ensured RQM+ stays at the forefront of MedTech.
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💬 New MedTech Voices Episode: Sally Sennitt and Jaishankar Kutty, Ph.D. dissect the expert panel's review of a groundbreaking extravascular implantable cardiac defibrillator (ICD) and offer insights into regulatory challenges and cardiac care innovation.
Takeaways: 👇
Expert Review Insights for a Novel Extravascular ICD: Get an insider's perspective on the stringent review process by the EU expert panel, including the critical evaluation of safety, efficacy, and novel features of the device.
Data Analysis Deep Dive: Discover the importance of comprehensive data in device approval, from early feasibility studies to pivotal trial results, and how this impacts device certification.
Navigational Guide for Manufacturers: Essential strategies for #MedTech manufacturers on conducting clinical trials, ensuring regulatory compliance, and addressing the expert panel's concerns to accelerate innovation to market.
Future of Cardiac Devices: Engage with these two thought leaders (please ask questions in the comments if you have them!) on the evolution of cardiac care technologies, the role of continuous data assessment, and the significance of post-market surveillance in validating long-term device performance.
There's a ton to unpack in this one and we hope you come away with value after watching! 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🌟 A seasoned expert in global regulatory affairs and project management, Senior Manager Laurie Pettit, PMP shares her journey in our newest Excellence Spotlight interview.
Here's why Laurie is an invaluable asset to RQM+ and our clients:
🌍 Global Regulatory Savvy: From her biology beginnings to navigating the complex pathways of international regulations, Laurie's career spans many roles and geographies. Her deep understanding of global requirements combined with a hands-on approach has been instrumental in guiding RQM+ clients through intricate compliance challenges.
🔬 Scientific Acumen: Laurie's foundation in molecular biology and her initial aspirations in research have shaped her meticulous attention to detail. This scientific precision has been pivotal in her success in managing quality and regulatory processes, ensuring every project meets the highest standards.
🛠️ Project Management Whiz: Transitioning into project management was a natural evolution for Laurie, reflecting her ability to steer complex regulatory submissions and strategic initiatives. Her role as a portfolio owner at RQM+ highlights her expertise in aligning business objectives with regulatory requirements, ensuring client success.
Continuous growth, learning, and adapting to the evolving needs of the MedTech industry perfectly describes Laurie. Like many at RQM+, her ability to bridge the gap between regulatory requirements and business objectives makes her a cornerstone of the team.
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MedTech Moments are a curated selection of the most impactful snippets from our expert panel discussions. This clip was taken from RQM+ Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance.
What makes a good EU MDR program from a maintenance perspective?
We answered this question in RQM+ Live! #72, featuring:
- Sharmila Gardner – Technical Documentation Manager & Head of UK Approved Body, Intertek
- Brian Dahl – Vice President of Quality and Regulatory, Starkey Hearing
- Jaishankar Kutty, Ph.D. Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+
🎥⏯️🕗 Watch the entire panel and see the questions we covered on demand here.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Meet Nicholas Wilson, Ph.D. – Principal, Clinical and Post-Market Practice – in our new Excellence Spotlight interview.
What makes Nicholas special? A lot! Please listen to his story in the interview, but here are just a few reasons RQM+ clients love working with Nicholas:
🌍 Global Expertise: From his beginnings in New Zealand to significant stints in Sydney, Barcelona, Abu Dhabi, Zurich, and the UK, Nicholas's international experience has given him an unparalleled perspective in clinical research and regulatory strategies. His diverse background and first-hand understanding of complex global regulations helps him to be a trusted advisor to RQM+ clients worldwide.
📊 Data Analysis and Research: Nicholas's interest in research led to his impressive credentials, including seven peer-reviewed publications as the first author. His expertise in analyzing and interpreting complex data is a cornerstone of his approach, ensuring our RQM+ clients benefit from data-driven insights and strategies.
🧠 Technical Lead: Nicholas is the technical lead on various projects, adeptly managing medical writers and steering projects to successful conclusions. His ability to translate intricate medical concepts into actionable strategies is a testament to his profound technical knowledge and leadership skills.
Nicholas's path is a vibrant one of risks, challenges, and continuous learning, making him an incredibly valued and unique member of the RQM+ team. Over the course of his career, he's pushed the boundaries of what's possible in clinical research and regulatory strategy. All of us - colleagues at RQM+, clients he impacts, and the industry he helps shape - are better for it. 🙏
PS – Thank you as always to Jaishankar Kutty, Ph.D. for the interview!
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Have you seen the proposed amendments to MDR and IVDR published this week? Margot Borgel, Ph.D. and Jaishankar Kutty, Ph.D. sat down to discuss the details of this proposal, the potential impacts to manufacturers, and some questions and concerns surrounding this proposal.
All current transition timelines have been extended by 2.5 years with new deadlines ranging from 31 December 2027 for highest risk devices to 31 December 2029 for the lower risk devices.
There are some conditions around these transition deadlines, including:
- No significant changes can be made to the device
- PMS and vigilance requirements under IVDR must be met
- An IVDR compliant QMS must be implemented by 26 May 2025
- An application must be lodged with the notified body at least two years ahead of the transition deadlines
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This show was recorded 18 January 2024. Download the slides from this presentation (including bonus slides not presented) by submitting the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com.
Thank you for tuning in. 🙏
Brief
With the forthcoming restrictions on Per- and Polyfluoroalkyl Substances (PFAS), medical device manufacturers are on the brink of a significant industry shift. PFAS, known for their versatile properties, have been integral in the production of various medical devices. However, with the phase-out of these substances by the end of 2025, manufacturers must navigate the transition with precision and strategic foresight.
This session will begin with a short presentation to set the stage, and will be followed by a panel discussion bringing together RQM+'s leading experts in regulatory affairs, quality assurance, and lab services, to delineate a proactive approach for manufacturers.
We will dissect the three-step process required to phase out PFAS used in medical devices, addressing the identification of alternative materials, the intricacies of materials testing and verification, and the critical steps for successful documentation submission to regulatory bodies.
Topics with timestamps
00:00:00 - Introduction and Agenda Setting
00:02:12 - Introduction of Panelists
00:04:51 - Impact of 3M Exiting the Business
00:07:42 - Understanding the Supply Chain and Material Changes
00:10:32 - Concerns with Finding Alternative Materials
00:13:28 - Preliminary Testing for Material Replacements
00:16:07 - Limitations in Impact Assessment and Supplier Engagement
00:18:39 - Environmental Concerns and Supply Continuity
00:21:28 - Regulatory Impact
00:24:23 - Identifying and Restricting PFAS
00:27:26 - Implications of Material Changes in Medical Devices
00:30:11 - Considerations for Material Changes under EU Regulations
00:32:51 - Data on Dose Response for Safety Standards
00:35:21 - The Challenges of Chemical Characterization
00:38:08 - Considering Potential Material Changes in FDA Submissions
00:41:00 - Potential Impact on Performance Specifications
00:43:45 - Evaluating Biological Safety Risks
00:46:34 - Minimizing Testing Burden and Overwhelming Notified Bodies
00:49:06 - The Importance of Clinical Evaluations
00:51:45 - Impact on Clinical Evaluation and Biological Safety
00:54:27 - Sensitivity and Analytical Instrumentation
00:57:18 - Chemical Characterization and Contamination
01:00:04 - The Importance of CEM characterization and supplier controls
01:02:46 - The Importance of FDA Buy-in
01:05:48 - Explaining the Thinking Behind the Process
01:08:38 - Risks in Material Manufacturing
01:11:31 - The Benefits and Challenges of Targeted Analysis
01:14:12 - Material Change and Analytical Terms
01:17:07 - Detailed Risk Assessment and Impact Assessment
01:20:16 - Ensuring the Availability of Critical Products
01:22:21 - Conclusion
Panelists
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation
- Kevin Rowland – Director of R&D
- Taryn Meade – Director of Biological Evaluation Consulting
- James Wrenn – Director of Solutions Delivery
- Alexia Haralambous – Senior Principal (former FDA)
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
2️⃣ things we're excited about today...
1. Our new Excellence Spotlight interview featuring RQM+ Senior Principal and former FDA-er Alexia Haralambous – a mastermind in spinal devices and global regulatory affairs.
2. Alexia has just been added as a panelist to next week's RQM+ Live! show: Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers. Will you join? If interested, please RSVP at the link in the comments. In addition to the discussion, we'll be sharing a short presentation, too. All who RSVP will receive an exclusive download of the slides presented, as well as bonus content... perfect for sharing with colleagues (including managers).
Back to Alexia! Here's just a snippet of what she brings to RQM+ and our clients:
Technical Strength: Alexia's journey, starting at Johns Hopkins and leading through pivotal roles at the FDA and Stryker, has honed her into a global regulatory expert. Her comprehensive experience and technical capability have proved to be an enormous benefit for the clients she supports.
From FDA to Industry: Her transition from FDA reviewer to industry leader wasn't just a career change, but a stepping stone to greater challenges and achievements. At Stryker, she gained insights and experience with quality management systems, EU MDR, and global strategy, rounding out her understanding of industry operations.
Global Regulatory Expert: At RQM+, Alexia applies her skills across a variety of therapeutic areas, supporting startups and larger companies alike. Her diverse experiences make her an invaluable resource for our clients... and in next week's PFAS panel discussion!
Alexia's expertise and adaptability exemplify the spirit of RQM+. Her ability to synthesize a wide range of experiences into effective strategies makes her a standout member of our team. We think if you watch her full interview there's a lot to learn from her unique perspective.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🎆 Happy new year! We're bringing the most positive energy we can to start 2024 with a heartwarming and uplifting RQM+ Excellence Spotlight interview with Niki Caporali Spaniel, RAC.
Niki's journey blends a deep-seated passion for healthcare with an extremely impressive command over regulatory strategies, reflecting a career built on empathy, expertise, and a commitment to advancing MedTech.
What does Niki bring to the table for RQM+ clients? Two highlights:
🛠️ Technical Excellence: With a sharp eye for regulatory nuances, she's been instrumental in steering clients through challenging landscapes, turning obstacles into opportunities for growth and compliance.
💞 Empathetic Leader: Niki's warmth and empathy (watch or listen to the interview!) resonate in every project and her genuine care for clients' success is clear at every step. Niki turns a sometimes impersonal world of regulations into a journey of shared goals and mutual success.
Again, we thought Niki's interview was the perfect way to start off the new year. Her story is a reminder of the incredible human element behind every medical breakthrough. Please feel free to comment and join us in celebrating Niki's wonderful story and the meaningful impact she has on RQM+, our clients, and the wider MedTech community. 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🎄 This week's Excellence Spotlight shines on a standout member of our clinical and post-market team, Senior Consultant / Capability Manager, Lindsay Wright.
A snapshot of what Lindsay brings to RQM+ and our clients 👇
Biomedical Engineering and Mechanical Engineering Ingenuity: Lindsay started her journey at the University of Pittsburgh, first excelling in bioengineering, then going further, receiving her master's degree in mechanical engineering.
Translating Science to Solutions: Lindsay’s transition from regenerative medicine to regulatory affairs illustrates her ability to apply scientific principles to real-world challenges. Her experience in R&D and regulatory roles at RQM+ has been instrumental in navigating the complex pathways to market for diverse medical devices and IVDs.
Client Collaboration: Lindsay excels in synthesizing varied inputs and collaborating with diverse teams, allowing her to deliver regulatory documents of the highest standard.
We think Lindsay perfectly embodies the consistent pursuit of knowledge and the versatility required in the ever-evolving landscape of medical device regulation. RQM+ is proud to have Lindsay as a key contributor to our success and the success of our clients. 🙏
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After a lull which has now picked up with FDA approvals, what's next for renal denervation? RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. shares the knowns and unknowns in a new video clip.
📝 Quick summary
Renal denervation is a technology that aims to control blood pressure by disrupting renal nerve activity through a minimally invasive, irreversible procedure. Clinical trial data is mixed, with modest reductions in blood pressure observed. Skepticism and uncertainties surround the technology due to risks, lack of markers for procedural success, and unclear durability of benefits.
The post-market phase is crucial for generating more data and addressing unanswered questions. Patient population and risk-stratified benefit-risk analysis are important considerations, and a clinical outcomes study is needed to evaluate the impact of renal denervation on cardiovascular events.
💭 Takeaways
- The state of play and the adjunctive nature of renal denervation in treating resistant hypertension in some patients.
- Strong focus on what’s lacking from a benefit-risk perspective today and what needs to be studied in the post-market phase.
🕒 Timestamps
00:00 Introduction and Background
01:26 Renal Denervation as a Therapy for Hypertension
02:25 Technology and Procedure of Renal Denervation
03:21 Clinical Trials and Efficacy of Renal Denervation
04:46 Skepticism and Uncertainties Surrounding Renal Denervation
06:15 Post-Market Phase and Expectations
07:41 Challenges and Questions for Renal Denervation
08:58 Patient Population and Benefit-Risk Analysis
10:15 Risks and Modest Benefits of Renal Denervation
10:44 Need for Clinical Outcomes Study
11:14 Conclusion
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ Today's Excellence Spotlight features Principal RA/QA Rostislav Stoykov. With a strong foundation in biomedical and clinical engineering, Rostislav has masterfully navigated the complex regulatory landscape and made significant contributions in the medical device industry.
Highlights from his conversation with Jaishankar Kutty, Ph.D.:
🎓 Biomedical and Clinical Engineering Roots: Rostislav’s journey began with a dual degree in biomedical and clinical engineering, a remarkable start that set the stage for his multifaceted career. His technical ability laid the foundation for his future successes in product management and RA/QA roles.
🌐 Navigating Regulatory Landscapes: With roles ranging from leading MDD remediation programs to being the regulatory lead for global legal manufacturers, Rostislav's experience is vast. Perhaps most impressive and as Jai points out in the interview, has been his consistent ability to remain calm and find successful paths in many challenging regulatory scenarios.
🧩 Holistic RA/QA Approach: Rostislav emphasizes the inseparability of quality and regulatory aspects in the medical device field. His expertise in both areas has allowed him to tackle comprehensive challenges and implement effective solutions, ensuring the delivery of high-quality, compliant products.
Rostislav exemplifies the blend of technical knowledge, strategic thinking, and regulatory acumen that is essential for the highest performance and impact in today's device industry. This is exactly what RQM+ strives to bring to every client and project.
RQM+ is proud to have Rostislav as a key member of our team, continually elevating our capabilities and impact in the industry. 🙏
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🚨 Hear Jaishankar Kutty, Ph.D. discuss the critical impact of PFAS phase-out on medical device manufacturing and then, 🎟️ RSVP to our January 2024 event for exclusive downloadable content.
We hope you find Jai's commentary to be an excellent summary of the topic! Our January presentation and panel, Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers, will go significantly deeper, providing proactive strategies to navigate this major shift.
A few quick takeaways from Jai's clip...
🔬 PFAS substances have significant ramifications on medical device and IVD manufacturing.
🇪🇺 The proposed EU reach restriction and 3M's decision to stop manufacturing PFAS substances have regulatory and supply chain implications.
🔍 Device manufacturers need to identify PFAS substances used in their products and find alternate materials.
⚖️ Regulatory assessments and potential legal ramifications should be considered in the process.
Again, for substantially more on this topic and exclusive content, RSVP for the brief presentation and panel at this link.
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🎟️ RSVP for the Jan. 18th panel and access exclusive downloads.
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This show was recorded 30 November 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. We have a ton of on-demand content there, too. Thank you for tuning in! 🙏
Takeaways
- LDTs have historically been subject to enforcement discretion by the FDA, but as they have become more complex and used in higher-risk settings, the FDA is proposing regulations to ensure their safety and effectiveness.
- Examples of issues with LDTs include false positive or false negative results, misdiagnosis, and fraudulent practices.
- IVDR regulations in the EU are influencing the FDA's approach to LDT oversight, and manufacturers may need to comply with both sets of regulations.
- Preparing for LDT regulations involves understanding the current LDT portfolio, identifying gaps in data and validation, and considering the impact on resources and timelines.
- Potential pitfalls include challenges in determining the classification of LDTs, ensuring compliance with validation requirements, and managing resource constraints.
- The proposed rule has received significant feedback and comments, with some expressing concerns about the need for regulation and the potential impact on innovation and patient access to tests.
- Implementing LDT regulations may require significant financial resources, including costs for testing, clinical trials, and quality management systems.
- The chances of the proposed rule going into effect are uncertain, but the FDA is committed to addressing the concerns and evidence of issues with LDTs.
Chapters
00:00 Introduction
03:25 History and Background of Laboratory Developed Tests (LDTs)
05:46 Impact of FDA Regulations on LDTs
08:41 Examples of Issues with LDTs
14:00 Speculation on the Regulatory Process
18:38 Influence of IVDR Regulations on FDA
20:38 Opportunities for IVD Manufacturers
25:51 Preparing for LDT Regulations
28:06 Potential Pitfalls and Challenges
35:15 Comparison of LDT Regulations with IVDR
41:41 Comments and Feedback on the Proposed Rule
44:35 Scenario: Using FDA-Cleared Test with Different Specimen Types
46:21 Supporting Team Members in Implementing Changes
51:49 Realistic Cost of Implementing LDT Regulations
52:14 Chances of Proposed Rule Going into Effect
52:18F DA's Mission and Authority to Regulate
53:17 Closing Remarks and Call to Action
Panelists
- Nancy Morrison, RAC – Vice President, Intelligence & Innovation
- Margot Borgel, Ph.D. – Director, IVD Intelligence & Innovation
- Eila Pattee, Principal Consultant
- Andrew Lakey, Ph.D. – Senior Consultant
- Theresa Miles – VP, Client Portfolio Management (moderator)
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PS - If you enjoyed this episode, please let us know by leaving a 5-star review! We'd appreciate it if you do and it will help more MedTech professionals discover our free content. ⭐⭐⭐⭐⭐🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ The plus is the people at RQM+ and today's Excellence Spotlight features Torrie DeGennaro, a star in biomedical engineering and quality assurance at RQM+. Torrie's innovative approach to PMCF data collection has been pivotal in securing MDR certification for numerous legacy devices. She's also a key contributor to our AI clinical evidence platform, Fern.ai.
Highlights from her conversation with Jaishankar Kutty, Ph.D.:
🧬 Biomedical Engineering Expertise: With a robust background in BME focusing on biomechanics, Torrie's journey from contract manufacturing to quality assurance showcases her depth in the field and adaptability to diverse roles in medical device development.
🌐 PMCF Innovation: Torrie's role in evolving PMCF data collection methods has not only supported MDR certification, but also opened new avenues for legacy device compliance. Her tenacity and innovative thinking have been key in navigating the challenges posed by changing regulations.
🤝 Teamwork and People Skills: Beyond her strong technical capabilities, Torrie's ability to collaborate effectively, adapt to new challenges, and lead projects underscores her exceptional interpersonal skills. Her capacity to work closely with teams and clients, understanding their unique needs and perspectives, sets her apart.
Torrie's journey is a testament to her sharp intellect and simply put, her ability to get things done. We're thrilled to have such a dynamic and versatile professional driving progress and excellence at RQM+ and for our clients. 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ Today's Excellence Spotlight proudly features our Director of Global Audit Practice, Dr. Richard Freeman. Richard's journey from academia to industry has made him a standout expert in product development, process development, and quality systems, to name just a few.
Highlights from Richard's interview with Jaishankar Kutty, Ph.D.:
🧪 Science and Innovation: Beginning his career with a strong focus on chemistry, Richard's passion for creating novel molecules and his expertise in organic synthesis have been instrumental in his success. His work in developing novel antibiotics and antiretroviral inhibitors exemplifies his commitment to impactful scientific advancement.
🌍 From Academia to Industry: Richard's transition from academic research to industry ("industry got lucky," as Jai points out! 🍀) highlights his adaptability and prowess in applying scientific knowledge to real-world applications. His experience in synthesizing chiral molecules and working on biocompatible coatings for medical devices demonstrates his ability to translate complex scientific concepts into practical solutions.
🌐 Global Impact: Richard's contributions extend beyond the lab. From aiding in the development of coronary stents to improving antimicrobial wound dressings, his work has had a significant impact on global healthcare. His role in shaping medical device regulations in Saudi Arabia and leading RQM+'s global audit practice underscore his influence in the field.
We think Richard's journey is a testament to one of the most important traits a person can have: curiosity. His diverse experience and ability to overcome complex challenges make him an invaluable asset to our team at RQM+. We're honored to have him with us, shaping the future of medical devices and healthcare. 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ In today's 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁, we're extremely excited to feature Senior Consultant Andrew Lakey, Ph.D. Andrew is a multidisciplinary scientist whose career spans academia, industry, and notified body experience, making him a vital asset to our IVD team.
Key insights from our interview:
🔬 From Forensics to IVDs: Andrew's journey began with forensic science, leading to a deep dive into microfluidics and nanotechnology. His transition to IVD diagnostics showcases his adaptability and dedication to scientific advancement.
🧪 Creative Problem Solving: Andrew's background in R&D has honed his problem-solving skills, particularly for developing innovative diagnostic solutions. His ability to think differently (🍏 Steve Jobs, is that you?) has been key to overcoming numerous R&D challenges.
🌐 Academic to Industry Transition: Moving from academia to a regulated industry environment, Andrew quickly adapted to stringent quality systems. This shift highlights his ability to evolve and master new areas, enhancing the RQM+ team's expertise in regulatory and quality aspects of IVD development.
Andrew's unique experiences – from aiding zoo elephants to navigating the complexities of IVD product development – definitely demonstrate his exceptional versatility and technical expertise. We're honored to have him at RQM+, where he continues to make significant contributions to the field and our clients. 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
💬 "Stay ready so you don't have to get ready." – Brandy Chittester, Senior Director of Clinical Operations
In a new Excellence Spotlight interview, we're thrilled to talk with Brandy Chittester, a key figure in clinical research at RQM+. Brandy skillfully bridges the gap between technical expertise and operational excellence.
Some highlights:
🔍 The Journey from Engineering to Clinical Research: Starting her career in mechanical engineering, Brandy's passion for biomedical applications led her to clinical research.
📈 Critical Thinking and Innovation: Brandy's engineering background has been fundamental in her success in clinical research. Her methodical approach to problem-solving ensures that every project under her watch is handled with precision and a keen eye for detail.
🤝 Mentorship and Team Building: Beyond her technical skills, Brandy excels in fostering team growth and mentoring new talent. Her philosophy of 'staying ready so you don't have to get ready' resonates deeply with our team, enhancing collaboration and staying true to everyone's commitment to excellence.
Brandy's unique blend of engineering acumen and clinical research expertise makes her an invaluable asset to RQM+ and our clients. We're proud to have her as a part of our team, continually driving innovation and excellence in clinical research. 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🎙️ Our Excellence Spotlight series proudly showcases the technical excellence personified by our team. Senior Principal Engineer, Hrishikesh Gadagkar, Ph.D., stands as a paramount example of this dedication.
Three highlights from our newest interview:
🛤️ Tech Trailblazer in Med Devices:
Leading from the front in areas ranging from diagnostic imaging to wearable technology, Rishi has a track record of steering complex projects to success. His skill in navigating the intricacies of product development and regulatory pathways is spectacular... as is his commitment to technical excellence in everything he does.
🔌 Scientific Insights and Innovation:
With a Ph.D. in Electrical Engineering and a 𝘸𝘦𝘢𝘭𝘵𝘩 of experience across medical device domains, Rishi stands out as an innovator. His journey from engineering breakthroughs to strategic regulatory approvals illuminates his role as a cornerstone at RQM+.
🤝 Empathetic Leadership and Mentorship:
Rishi's leadership extends beyond project management to embody the essence of mentorship. His empathetic approach and ability to cultivate a deep understanding of client needs make him an exemplary team player. His philosophy? To approach every challenge with the grace of a teacher and the focus of a scholar.
Rishi's contributions to RQM+, our clients, and the medical device industry are a testament to his exceptional expertise and steadfast dedication. A heartfelt thank you to Rishi for his influential impact and for setting a standard of excellence we all aspire to! 🙏
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🎥 Sally Sennitt and Jaishankar Kutty, Ph.D. are starting off this week with plenty of good things to say in a new MedTech Voices video.
This time, they unpack the EU MDR expert panel's evaluation of a novel resorbable device aimed at revolutionizing hernia repair procedures.
Why watch (or listen) 👇
🔍 Scrutinizing the Longevity of Resorbable Devices:
Understand the balance between durability and resorption rates in implantable devices and why this matters for patient outcomes.
🌐 Exploring the Interplay of Device Design and Clinical Trials:
Discover the implications of a device’s material composition, such as P4HB and PGA, on its performance and the intricacies of clinical trial design that capture this data effectively.
🔬 Data Assessment Through an Expert Lens:
Learn how the expert panel dissect presented data — from safety to performance — and the significance of stratification in clinical evidence for specific surgical applications.
📊 Emphasizing Post-Market Surveillance:
Explore the crucial role of post-market clinical follow-up (PMCF) plans and how they contribute to understanding the long-term impact of medical devices.
📝 Critical Analysis of Notified Body and Manufacturer Data:
Hear how a well-conducted review can influence the perception of a device's safety and performance, and what the consensus from an expert panel signifies for the future of device approval.
As always, if you have any feedback or questions we hope you'll let us know! 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ Meet Senior Director of Project Management Cari Kniola in our newest Excellence Spotlight interview 👇
Cari navigates clinical trials with expertise and commitment. Her 26+ years of experience in clinical research elevates the capacity of RQM+ to serve clients and drive innovation. Cari's journey into this field is as fascinating as her work, transitioning from a background in veterinary technology to becoming a linchpin in advancing medical device research.
🎯 Specializing in Medical Device Research
As an integral part of our clinical trial team, Cari specializes in regulatory submissions for medical device trials. Her deep understanding of regulatory frameworks and close relationships with both the FDA and European notified bodies ensures RQM+ clients have the best strategies for successful product approvals.
🔬 Expertise that Makes an Impact
Cari’s expertise is instrumental in helping our clients navigate complex regulatory landscapes. From initial trial designs to final submissions, she provides the kind of guidance that can only come from years of hands-on-experience. It’s team members like Cari who make RQM+ the go-to firm for the top medical device manufacturers.
🌐 Globally Recognized Talent
Cari’s contributions don't just benefit RQM+, they enrich the entire #MedTech industry. She regularly collaborates with top clinical researchers and has presented her research at international conferences. Her work has received accolades from industry peers and helped her become a globally recognized talent in the field.
We are grateful to have Cari as part of the RQM+ team, driving excellence in MedTech. 🙏
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This show was recorded 26 October 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for tuning in! 🙏
Listen in as Boston Scientific's Sr. Global Regulatory Intelligence & Advocacy Manager joined RQM+ experts for a special edition of our Live! show, all about the month's industry events! This session brings together insights from an array of events our team attended throughout October, such as the RAPS Convergence and The MedTech Conference (AdvaMed). We've soaked in knowledge, experiences, and taken note of industry updates. Now, we're excited to come together and share the crux of what we've discovered — the revelations, shifts, and noteworthy advancements.
We'll touch upon:
- Key topics from a broad spectrum of events
- Crucial shifts in industry practices and guidelines
- Overarching themes that resonated across various conferences
- Answering questions and providing clarity on intricate topics
Whether you attended any of the October events or not, this session is a golden opportunity to gain a consolidated perspective of the busiest month in MedTech and draw connections between different events.
Panelists:
- Olga van Grol-Lawlor – Sr. Global Regulatory Intelligence & Advocacy Manager, Boston Scientific
- Amie Smirthwaite, Ph.D. – Sr. VP of Intelligence & Innovation, RQM+
- Nancy Morrison, RAC – Vice President, Intelligence & Innovation, RQM+ (moderator as well)
- Dirk Steenmans – Global Head, Clinical and Post-Market Practice, RQM+
Timestamps:
- 4:11 -- What events did everyone attend and what was your role in those events?
- 8:19 -- Were there any trends you saw across conferences or that applied around the world?
- 21:07 -- It's understood that manufacturers are unhappy about the MDR, but precisely what aspects of the MDR are causing problems?
- 33:02 -- What was the most debated or discussed session at any of the conferences?
- 41:59 -- How do I find SSCPs posted on EUDAMED?
- 42:33 -- How complete is real-world evidence? What about the use of registries? What's the data being collected? (Amie's "IT DEPENDS" sign makes its first appearance!)
- 50:38 -- What is the latest on post-market surveillance? When can I stop doing PMCF? Do I need a WET device?
- 57:24 -- What are you most hopeful about?
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PS - If you enjoyed this episode, please let us know by leaving a 5-star review! We'd appreciate it if you do and it will help more MedTech professionals discover our free content. ⭐⭐⭐⭐⭐🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🎙️ Our Excellence Spotlight series and host Jaishankar Kutty, Ph.D. are back this week with a feature on RQM+ Senior Project Manager, Ethan Elshoff, MPH, MBA.
Three standout points from the interview:
📊 Mastery in Business Analytics and Healthcare Strategy: Ethan possesses a unique combination of business analytics, healthcare strategy development, and project management expertise. His educational foundation, with a Master's in both Public Health and Business Administration, positions him as a vital contributor for RQM+ and our clients.
⚙️ Leader in Operational Excellence: Steering the AI capability enhancements and clinical data collection programs, Ethan is at the forefront of driving our company's innovation. His role in developing the retrospective chart review data collection for PMCF activities showcases his dedication to ensuring our clients meet the highest standards.
🤝 Team Player with Outstanding People Skills: Whether he's working with technical or non-technical staff, Ethan has the natural ability to adapt and work cohesively. His approach, which he likens to water 💧, allows him to tailor his interaction based on the personalities and roles within a team.
As an integral part of RQM+, Ethan consistently showcases the incredible value he brings to our clients and the healthcare sector as a whole. As we always say and mean wholeheartedly at the end of these posts, thank you, Ethan, for your unwavering commitment and the unparalleled expertise you bring to the table every day! 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Today we're shining the spotlight on Principal Consultant Dr. Catherine Kang! We love this interview and hope you'll listen. With an engineering foundation, deep roots in biomaterials, cell biology, and tissue engineering, Catherine's expertise doesn't stop there. She stands tall in neuroscience, medical writing, and especially in combination products – merging drugs and devices.
🔍 Three highlights about Catherine...
From Research to Regulatory Mastery:
With a passionate start in academic research, Catherine elegantly transitioned to the regulatory world driven by her personal goals and a focus on family. Listen to the clip to hear how.
Combination Products Visionary:
We don't use "visionary" lightly! Catherine's vast experience enabled her to develop a quality system and processes that optimize the development of combination products, ensuring both compliance and effectiveness. This systemic approach has positioned her as a true industry leader in this space.
Commitment Beyond Work:
Watching this clip will make it obvious, but Catherine takes immense pride when her clients succeed, illustrating her dedication to collaborative victories... which is a theme at RQM+. You'll also learn her journey showcases an incredible balance between technical prowess and personal priorities, a testament to her character.
🌐 Value to RQM+ and clients...
Catherine's exceptional expertise in combination products sets her apart. Her unparalleled skills and continuous evolution in this niche space have made her an invaluable asset to RQM+ and our clients.
📚 For aspiring regulatory experts...
Catherine's journey exemplifies the power of continual learning, reinvention, and understanding priorities. She illustrates that with determination, one can seamlessly transition, grow, and excel in any chosen path.
Thank you, Catherine Kang, for your dedication, knowledge, and the immeasurable value you bring to RQM+ and our esteemed clients every day! 🙏
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🎥 Sally Sennitt and Jaishankar Kutty, Ph.D. are back and looking into the expert panel's insights on a shoulder replacement system; a device that has the potential to redefine orthopedic solutions.
Why you should watch 👇
📘 Deep Understanding of Clinical Evidence:
Dive into the intricacies of what constitutes 'sufficient' clinical data and why it's paramount in regulatory processes.
⚙️ Beyond the Basics:
Learn about the multiple facets and variables of shoulder replacement, its implications, and the criticality of data stratification.
👀 Tackling Challenges in Data Collection:
A closer look at the hurdles in gathering comprehensive data, addressing follow-ups, and deciphering the critical findings.
📈 Potential for Better Treatments:
Explore how improved data analysis and presentation can lead to groundbreaking treatments in the orthopedic space, making a difference in countless lives.
If you have any feedback or questions, please let us know! 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Meet RQM+ Director of R&D (and "detective" 🕵️) Kevin Rowland in our new Excellence Spotlight...
🔍 Two highlights about Kevin...
True Mastery in Analytical Chemistry:
Kevin’s foundation in engineering and chemistry allows him to employ high-end instrumentation and sophisticated methods to tackle the most challenging projects in analytical chemistry, ensuring the accuracy and reliability of results in highly regulated tests.
Development of Innovative Processes:
Kevin is proud to have developed transformative processes for chemical characterization projects along with a team of brilliant chemists. His innovations and publications have proposed new advantageous approaches and have contributed to creating safer, lifesaving medical devices.
🌐 Value to RQM+ and clients...
Kevin’s unmatched technical skills, profound problem-solving abilities, unwavering commitment to patient safety, and strong customer focus make him a valued asset at RQM+. Kevin is one of the key reasons we are able to consistently optimize the speed and quality of chemical characterization studies for clients.
🔬 Inspiration for aspiring scientists...
For anyone at the early stages of their career, Kevin’s journey illustrates the importance of not accepting the status qu and continually striving for improvement. His can-do, will-do, and must-do attitude spur innovation and progress in the scientific community.
Thank you, Kevin, for your unwavering dedication and the incredible value you bring to RQM+ and our clients every day! 🙏
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This show was recorded 28 September 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for tuning in! 🙏
The extension of the EU MDR compliance timeline offers a reprieve for medical device manufacturers, but this extended window comes with its own set of challenges and conditions. As the interim deadlines approach, it’s critical for manufacturers to fully understand their obligations and the ramifications of failing to meet them.
In this high-impact panel discussion, thought leaders from a notified body, manufacturer, and RQM+ come together to unpack the complex landscape of EU MDR compliance in light of Regulation 2023/607 and the transition from MDD/AIMDD to MDR 2017/745.
This is a must-attend session for those dealing with legacy device transitions and meeting upcoming MDR deadlines.
Topics include:
- Understanding key dates: The anatomy of interim deadlines and the conditions for extended transitional arrangements
- Mastering documentation: What manufacturers need to include in their MDR applications for a successful assessment by notified bodies
- Staying compliant: Best practices for incorporating the requirements of MDR 2017/745 into existing Quality Management Systems
- Certificates and self-declarations: Proving the extended validity of your device’s CE certificate and navigating self-declaration protocols
- Risk management: Avoiding common pitfalls that can delay or derail your transition to MDR compliance
- A look into the future: How early compliance can give manufacturers a competitive edge and allow for design and market adaptability
Attendees will leave the session equipped with actionable insights for navigating this complex regulatory environment, including a deeper understanding of the strategic and tactical steps needed for a successful transition.
Panelists:
- Sharmila Gardner – Technical Documentation Manager & Head of UK Approved Body, Intertek
- Brian Dahl – Vice President of Quality and Regulatory, Starkey
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+
- Matt Burger – Vice President, Business Development, RQM+ (moderator)
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PS - If you enjoyed this episode, please let us know by leaving a 5-star review! We'd appreciate it if you do and it will help more MedTech professionals discover our free content. ⭐⭐⭐⭐⭐🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🌟 The plus is the people at RQM+ and our Excellence Spotlight series celebrates them... as well as the significant impact they have on our clients.
This week we're delighted to feature Principal Consultant Diane Cox, whose expertise in FDA, ISO, risk, and compliance within the medical device and IVD industries is an invaluable asset to RQM+ and the clients we serve.
We hope you'll watch, but here are some highlights:
🎓 Diane holds a degree in biology and began her journey in the lab managing DNA sequencing projects, garnering extensive experience in GLP compliance early in her career.
🧬 Despite her deep involvement with the complexities of DNA sequencing, she emphasizes the importance of simplification in quality processes to avoid misinterpretation and to ensure conciseness and clarity for diverse audiences.
🤝 Diane is not just a scientist; she's an empathetic listener, seeking to understand clients thoroughly before offering solutions, ensuring their concerns are addressed and their company cultures are respected.
🌿 She's driven to develop and improve processes that are enduring and impactful for the users, reflecting her strong commitment to patient safety and quality improvement.
🔄 Diane’s ability to maintain and nourish client relationships post-project completion is noteworthy, creating a cycle of trust and mutual growth between her and the clients.
We find Diane’s journey inspiring and hope you do, too! Her devotion to fostering relationships and her commitment to excellence (we hope you've noticed this theme with all of our Excellence Spotlight clips) are critical to RQM+ and the success of our clients. A huge thank you to Diane for her enduring passion and dedication, and also to Jaishankar Kutty, Ph.D. for leading the interview. 🙏
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This show was recorded 21 September 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for tuning in! 🙏
We all know: ensuring the safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers.
One of the key challenges in achieving this goal is selecting and managing materials effectively, while maintaining supplier controls and identifying opportunities for proactive design changes.
In this panel discussion, experts in medical device development, regulatory compliance, and material science will share their insights on navigating material risks and implementing strategies to improve medical device safety.
Topics will include:
- Best practices for material selection and supplier controls in medical device development
- Strategies for proactive risk management, including early identification and mitigation of material-related risks
- Approaches to biocompatibility testing and regulatory compliance in medical device development
- The changing landscape of medical device regulation and its impact on material selection and supplier controls
- Case studies and practical examples of effective material risk management in medical device development
Attendees will come away from this session with a better understanding of how to navigate material risks in medical device development and implement effective strategies for improving safety and quality.
Panelists
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+
- Kevin Rowland – Director of R&D, RQM+
- Taryn Meade – Director of Biological Evaluation Consulting, RQM+
- Christine Santagate – Chief of Staff, Lab Services (moderator)
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🎥 We're starting off the week right with a NEW MedTech Voices 🚨
Join our Medical Director Sally Sennitt and VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. as they dissect the expert panel review of a groundbreaking neurostimulator designed to treat focal epilepsy in adults. 🧠⚡
Why watch?🤔
1️⃣ Gain Insights into the Complexities of Regulatory Approvals:
Understand the expert panel's concerns over data sufficiency and quality, and learn why a well-defined intended use is crucial.
2️⃣ Learn the Importance of Comprehensive Data:
Dive into the nitty-gritty of patient selection, stimulation parameters, and electrode locations; see what’s lacking and what could be improved.
But there's more...
👀 Extra Focus on Safety & Performance:
This clip raises important questions about the device’s safety in terms of its impact on seizure frequencies, which translates to several valuable lessons applicable to a wide range of devices.
📈 Potential for Patient Impact:
Given the prevalence of refractory epilepsy and limitations of existing treatments, it's easy to appreciate the significant opportunity this device could present... if only the data were better analyzed and presented.
We encourage any discussion in the comments and would love to hear your thoughts or questions about this complex, innovative device. 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
🌟 Today, we’re delighted to present another episode of our Excellence Spotlight series, featuring RQM+ Senior Principal Engineer, Pooja Roychoudhury!
🛠 With over 12 years (!) at RQM+, Pooja is a tour de force in design quality engineering, risk management, usability, 𝘢𝘯𝘥 𝘴𝘰 𝘮𝘶𝘤𝘩 𝘮𝘰𝘳𝘦, as you'll hear in the clip. Her multi-disciplinary educational background, including engineering and an MBA, has set the stage for her to be a role model in what we call the six C's of Learning – from critical thinking to customer success.
💕 But what truly sets Pooja apart are the life-changing impacts of her projects. She was instrumental in the development of a migraine drug that drastically improved a patient's quality of life, and she's even seen her work on a neonatal CPAP system help a neighbor's infant just released from the NICU. These moments provide her with the unstoppable energy she definitely has to keep improving human lives every day.
Thank you, Pooja, for your invaluable contributions to RQM+ and the broader medical community. 🙏
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This show was recorded 31 August 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for listening!
Certification of Class D devices present additional challenges for manufacturer's due to the additional requirements for these high-risk devices.
The challenges are further complicated because the infrastructure required in the IVDR is not fully in place. While notified bodies are moving forward with certification of these devices, the path forward and current state of play can be confusing. The targets seem to be constantly changing, making it difficult to prepare for certification of these devices.
In this Live! show we discuss:
- Current status on EURLs and draft common specifications
- What steps notified bodies are taking in lieu of EURLs
- What can you do to be prepared for your technical review
- And much more, including answering your questions!
Panelists:
- Margot Borgel – Director, IVD Intelligence & Innovation
- Bethany Chung, Ph.D., RAC – Principal Regulatory Scientist
- Lindsay Wright – Senior Consultant / Capability Manager
- Nancy Morrison, RAC – Vice President, Intelligence & Innovation (moderator)
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
🔦 Today, we're back with a BONUS Excellence Spotlight video featuring two case studies from Vice President of Technical, Jonathan Gimbel. Here's a link to Jon's original feature if you haven't seen it.
While these case studies will obviously demonstrate Jon's wealth of experience in action (even though he's shy about it!), we also hope they demonstrate the true depth of expertise at RQM+ and our dedication to helping clients through a multitude of challenges, including navigating the complex landscape of regulations and quality standards.
👷♂️ Case Study 1: From Ground Up to Success 👷♂️
Jon collaborated with a small company that had a groundbreaking wound healing device for negative pressure wound therapy. With a strong belief in their product but limited regulatory understanding, Jon and the RQM+ team stepped in. They meticulously audited the company, identified gaps, and much more. From developing a comprehensive quality system to guiding them through FDA audits and even drafting the 510(k) submission, this partnership yielded a full-service solution.
🏥 Case Study 2: Transforming Adversity into Collaboration 🏥
Amid recalls and warning letters, RQM+ played a pivotal role in restoring harmony at a company facing challenges with understanding FDA requirements. By assisting in recall resolutions, obtaining critical 510(k) submissions, and fostering a collaborative relationship with the FDA, Jon and the team transformed an adversarial dynamic into a collaborative one.
Again, we hope these case studies demonstrate RQM+'s commitment to supporting clients through every twist and turn! At RQM+, we're thankful for Jon's deep knowledge and leadership.
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🎬 In our latest MedTech Voices clip, RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. and Medical Director Sally Sennitt delve into the EU MDR expert panel feedback about a groundbreaking minimally invasive tricuspid valve.
Why watch? 🤔
1️⃣ Gain a comprehensive understanding of the intricate balance between benefit and risk as the clip explores the imperative of a Randomized Controlled Trial (RCT) for precise evaluation against guideline-driven medical therapy. The significance of an extended follow-up period is also underscored.
2️⃣ Navigate Post-Market Clinical Follow-up (PMCF) planning, as Sally and Jai dissect the study design's nuances, delineate the pursuit of well-defined endpoints, and scrutinize the determination of acceptable reduction in TR.
3️⃣ Uncover the convergence of regulatory and clinical considerations that ultimately led the expert panel to their decisive determination regarding the device's market readiness.
We'd love to hear any thoughts or questions you have about this episode in the LinkedIn comments! Thank you for listening. 🙏
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When we say we have thought leaders at RQM+, we mean it. 👑
Small in duration but big in substance, this four-minute MedTech Voices clip features Senior VP of Intelligence and Innovation Amie Smirthwaite, PhD, FRAPS sharing her ISO 18969 journey.
We don't want to say too much because we'll spoil the clip!
What we will say is that Amie's initiative is leading to the development of the first ISO standard for clinical evaluation of medical devices. Work is ongoing; while the standard will be harmonized, it's intended to be applicable to any regulatory geography, and emphasizes a scientific approach rather than addressing specific regulations.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
🌟 Today as part of our Excellence Spotlight video series we're celebrating RQM+ Principal Regulatory Scientist, Bethany Knorr Chung, PhD, RAC!
🔢 Bethany is a driving force behind our clinical and post-market operations group. With an exceptional background in math, biology, and biomedical engineering, she's truly a maestro of all things quantitative.
👪 Bethany's journey is a testament to her unwavering commitment to excellence personally and professionally. Following a brief hiatus to prioritize her family, she made a powerful comeback to the workforce. Her technical expertise and passion for what she does allows her to fearlessly dive into diverse projects, from catheters to neural implants.
🥇 As she covers in this clip with Jaishankar Kutty, Ph.D., Bethany's proudest achievement lies in revolutionizing quantitative benefit-risk analysis. Her pioneering method, lauded by reviewers, adds a new dimension to our industry's understanding.
Thank you, Bethany, for all you do for RQM+ and our clients!
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This show was recorded 27 July 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for listening!
Listen to a captivating and informative conversation aiming to help you master EU compliance, where BSI's Global Head Clinical Compliance Richard Holborow and RQM+'s Senior Vice President of Intelligence and Innovation Amie Smirthwaite come together and address current challenges and provide valuable insights on navigating the complex landscape of EU regulations.
This conversation will:
- Empower manufacturers
- Alleviate fears
- Equip manufacturers with practical guidance to succeed in the European market
Richard and Amie at a glance...
- Richard: Unparalleled insider knowledge from renowned notified body BSI, sharing exclusive industry insights
- Amie: Seasoned regulatory professional and former notified body leader, with extensive manufacturer feedback and practical experience
Key topics of discussion:
- Notified body capacity: Current status and future outlook, with insights into the impact of regulation 2022-14 and collaborative efforts among notified bodies
- Overcoming challenges: Strategies for both legacy and new devices, ensuring successful market access and maintaining a robust product pipeline in Europe
- Streamlining the certification journey: Easy fixes manufacturers can implement to improve submissions, enhance the certification process, and simplify their path to compliance
- Certificates with conditions: Latest developments, common challenges, and guidance on effective approaches
- And more! Additional insights and topics to provide a comprehensive understanding of EU regulations, including answering your questions!
Benefits for listeners:
- Gain exclusive insights and industry knowledge from insiders
- Demystify EU regulations and alleviate fears
- Obtain practical guidance to navigate the European market successfully
- Learn actionable strategies to enhance submissions and streamline the certification process
- Stay updated on certifications and conditions
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🎬 In a new eye-opening episode of MedTech Voices, Medical Director Sally Sennitt and VP Jaishankar Kutty, Ph.D. – a true expert on cardiac valves – explore the EU MDR expert panel feedback from a minimally invasive tricuspid valve.
🩺 The submitted data from a single-arm study with a short six-month follow up, was found to be insufficient and lacking in quality and quantity... and not supporting a benefit-risk profile.
You'll learn considerably more from watching (or listening to) the 10-minute clip, but a few points:
1️⃣ The device's benefit-risk profile was not considered positive, highlighting the need for an RCT (Randomized Controlled Trial) comparing it against guideline-led medical therapy. Also, a six-month follow up was deemed not good enough for a CE marking.
2️⃣ The PMCF (Post-Market Clinical Follow-up) plan was underwhelming and raised several concerns. The study design lacked clear endpoints and didn't provide enough insight into what constitutes acceptable reduction in TR.
3️⃣ Regulatory and clinical reasons led the expert panel to conclude that this device is not ready for the market.
This episode serves as a critical reminder for the entire MedTech community to be vigilant about the quality of submissions to notified bodies. We must ensure we uphold the highest standards, especially during this significant juncture for the EU MDR.
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This show was recorded 29 June 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for listening!
This panel discussion was all about the FDA's latest pre-submission guidance, with an emphasis on best practices for Predetermined Change Control Plans (PCCP). As always, we took questions from the audience and answered as many as we could!
Key points of discussion included:
- Unveiling FDA's new pre-submission guidance and its implications
- Pros and cons of implementing pre-submission meetings for regulatory success
- Leveraging pre-submission meetings for QSR follow-ups and risk mitigation
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A thorough exploration of PCCP (beyond just software); some specifics include:
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Applicable to PMA and 510(k) devices (previously not available for 510k devices unless the predicate had one)
- Includes labeling for the proposed change and performance requirements for changes made under the plan
- Allows manufacturers to make pre-planned changes without a new submission
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If choosing a predicate, it must be what was reviewed by FDA and not the device version that underwent a change control plan
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Understanding the 2022 Omnibus Appropriations Bill: Streamlining PCCP submissions
- How RQM+ empowers clients with comprehensive support in this area, from package preparation to remediation
Don't miss this opportunity to explore the advantages, potential challenges, and optimal approaches to leverage pre-submission meetings and PCCPs. We hope you’ll join our experienced and versatile team as they explore these topics and answer your questions.
Panelists:
- Nancy Morrison, RAC – Vice President, Intelligence & Innovation
- Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation
- Hrishikesh Gadagkar – Principal Engineer
- Bryan Pinder, RAC – Principal Engineer (former FDA CDRH Lead Reviewer)
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
Thanks for all the warm messages and feedback in response to our first Excellence Spotlight two weeks ago with Eila Pattee, MS, MLS(ASCP), RAC. Now it's time for round two!
🌟 In this latest episode, we're delighted to introduce none other than Vice President of Technical, Jonathan Gimbel, Ph.D. A problem solver through and through, this clip goes deep into what's made Jon successful. We think there are some incredible insights to learn from Jon's journey and apply to your own career.
Questions asked by Jaishankar Kutty, Ph.D.:
❓ Can you walk us through aspects of your educational background and path that enable you to be successful on a day-to-day basis at RQM+ and can you talk about your specific focus areas?
❓ What are some of the specific technical aspects that enable you to be successful on a daily basis?
❓ One you're in the deep end, you have to wallow through the grey and come up with successes. How do equip yourself to do that? What are some of the mental aspects that you recruit to help you be successful?
❓ What are some of your key achievements and what gets you excited on a daily basis?
We hope you enjoy! And we can't share an Excellence Spotlight without saying what RQM+ is all about: the plus is the people.
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📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
At RQM+, 𝐭𝐡𝐞 𝐩𝐥𝐮𝐬 𝐢𝐬 𝐭𝐡𝐞 𝐩𝐞𝐨𝐩𝐥𝐞.
We've been saying it, but now it's time to 𝒔𝒉𝒐𝒘 𝒚𝒐𝒖. 🎥
We're thrilled to unveil a new video series shining a spotlight on the outstanding individuals who help keep our clients moving forward!
🔦 Introducing the Excellence Spotlight series, where we celebrate exceptional talents and showcase the remarkable journeys and achievements of employees. We're starting with Principal, Eila Pattee, MS, MLS(ASCP), RAC.
🏅 We dive into Eila's journey at RQM+ and how she's made a lasting impact in the MedTech industry.
Through this series, we aim to inspire and uplift those who strive for excellence. The plus is the people at RQM+, after all!
--
📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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🗣️ We're excited to release the fifth installment of our MedTech Voices mini series about 𝐄𝐔 𝐌𝐃𝐑 𝐄𝐱𝐩𝐞𝐫𝐭 𝐏𝐚𝐧𝐞𝐥 𝐅𝐞𝐞𝐝𝐛𝐚𝐜𝐤. If you've been following along, this series is all about sharing perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year.
𝘐𝘴 𝘵𝘩𝘦 𝘳𝘦𝘱𝘰𝘳𝘵 𝘥𝘪𝘴𝘤𝘶𝘴𝘴𝘦𝘥 𝘪𝘯 𝘵𝘩𝘪𝘴 𝘤𝘭𝘪𝘱 𝘴𝘦𝘯𝘥𝘪𝘯𝘨 𝘢 𝘣𝘢𝘥 𝘮𝘦𝘴𝘴𝘢𝘨𝘦 𝘵𝘰 𝘮𝘢𝘯𝘶𝘧𝘢𝘤𝘵𝘶𝘳𝘦𝘳𝘴? 🤔
👨🏫 Jaishankar Kutty, Ph.D., VP of Intelligence and Innovation, is joined once more by Medical Director 👩🏫 Sally Sennitt. This clip focuses on a transcatheter heart valve – likely a balloon-expandable valve – and the report wasn't positive (even troubling). Our experts go into meaningful detail as to why.
Questions covered 👇
1️⃣ What was your overall feeling about this one?
2️⃣ What were some of your takeaways on the panel's comments and what was submitted to them?
3️⃣ What does this mean for manufacturers?
We appreciate you listening!
📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
📚 See on-demand content in our Knowledge Center.
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📢 We're thrilled to unveil our latest MedTech Voices video!
This clip is the fourth installment in our 𝐄𝐔 𝐌𝐃𝐑 𝐄𝐱𝐩𝐞𝐫𝐭 𝐏𝐚𝐧𝐞𝐥 𝐅𝐞𝐞𝐝𝐛𝐚𝐜𝐤 mini series where our experts offer their perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year.
Jaishankar Kutty, Ph.D., VP of Intelligence and Innovation, is joined by Medical Director Sally Sennitt and the two discuss a unique heart valve for adults and children above the age of 12.
📦 Questions packed into the 9:58 clip:
1️⃣ What were the key triggers for the referral for this evaluation?
2️⃣ What data was actually submitted?
3️⃣ Was there a breakdown of pediatric data?
4️⃣ What did the panel make of all of this?
5️⃣ What about the summary and conclusions?
6️⃣ Can we summarize the main messages from this review?
Thanks for listening!
📲 Follow RQM+ on LinkedIn here.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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This show was recorded 25 May 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for listening!
This panel discussion is all about navigating off-label use and implementing strategies to improve medical device safety. As we all know, ensuring the safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers. However, one of the key challenges manufacturers face is how to identify and handle off-label use, especially with the transition to MDR 2017/745.
During the discussion, our experts in device development, regulatory compliance and clinical evaluation shared insights on how to manage off-label use, reduce indications, define indications and contra-indications, as well expand indications using real-world data from post-market surveillance. We dove into the complexities of post-market surveillance and the importance of PMCF data in identifying off-label use. We also explored strategies for optimizing regulatory efforts while maintaining patient safety.
Key questions for our audience include:
- Have you had to restrict or reduce the indications for your device as part of the transition to MDR 2017/745?
- Are you struggling to define your indications and contra-indications for your device?
- Have you started to see examples of off-label use cropping up as your PMCF data comes back in?
- Are you trying to expand your indications using real-world data from post-market surveillance?
- Are you struggling to handle instances of off-label use within your risk management process?
Our panelists provided valuable insights into these questions and more from the audience! We hope you'll give this show a listen.
Panelists:
- Dr. Tom Melvin, Associate Professor of Medical Device Regulatory Affairs - Trinity College Dublin (former HPRA)
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation - RQM+
- Dr. Sally Sennitt, Medical Director, Intelligence and Innovation - RQM+
- Ed Ball, Manager, Intelligence and Strategic Execution - RQM+
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This show was recorded 27 April 2023 and can be viewed on our website here. The website recording has clickable chapters allowing you to instantly jump to different questions/topics. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center.
What type of evidence is considered sufficient to comply with the MDR? While we've spoken about this extensively in the past, we'll explore more ways to arrive at the answer and address many more questions this RQM+ Live! show.
Perhaps in certain situations you're asking yourself, "What kind of clinical evidence do I need for my device?"
Our seasoned panelists will share ways to determine exactly that by sharing recent thought processes and examples. We'll set the tone upfront with a list of factors that affect the 'definition' of sufficient clinical data, generally speaking: intended purpose, novelty, benefit-risk profiles, number of indications, users, where it's used in the world and supportive non-clinical data... just to name a few.
What we'll cover:
- Less burdensome, yet effective ways to comply with clinical requirements, using examples from a variety of device types
- How do you collect clinical data for standard of care devices?
- How and when can you use Article 61(10) and what is an indirect benefit? Does it make sense for software devices?
- Is equivalence really no longer useable for Class III and implantable devices?
- Why monitoring the SOTA could potentially save your company from wasting resources and is much more than just another regulatory requirement
- Evidence for Annex XVI products (products with no intended medical purpose)
This will truly be a loaded session that our team is incredibly excited about! There's much to discuss and our goal, as always, is to provide as much actionable value as possible for you.
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Jon Gimbel, Ph.D. – Vice President, Technical
- Sally Sennitt – Medical Director, Intelligence and Innovation
- Bethany Chung, Ph.D., RAC – Principal
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Today's new installment of MedTech Voices revisits a series from last year on EU MDR Expert Panel Feedback, where Jaishankar Kutty, Ph.D. and Andreas Tarnaris M.D. offer their perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year.
👂 Why should you listen?
📑 Hear what is being submitted to the notified bodies by manufactures
📋 Hear what has been submitted by the notified bodies for expert panel review
🩺 Hear a clinician's perspective on what clinicians on the expert panel are reviewing and commenting on
This third episode focuses on an orthopedic device submitted by a notified body. Previous clips focused on an intro to the series (#1) and a Class III implantable device, which happened to be a bone graft intended for maxillofacial surgeries (#2). We'll link to both of these in the comments.
Thank you for listening!
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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Our experts are back for the final MedTech Voices episode in our 𝗧𝗿𝗮𝘃𝗲𝗿𝘀𝗶𝗻𝗴 𝘁𝗵𝗲 𝗣𝗮𝘁𝗵 𝗳𝗿𝗼𝗺 𝗖𝗘𝗥 𝘁𝗼 𝗣𝗠𝗖𝗙 series.
These two 10-minute clips combine clinician and notified body perspectives to share information that will help you avoid errors when approaching your PMCF activities.
Featured experts with LinkedIn profile links:
👩⚕️ Sally Sennitt, M.D. – Medical Director
👨⚕️ Andreas Tarnaris M.D. – Medical Director
👨💼 Jaishankar Kutty, Ph.D. – Vice President of Intelligence and Innovation
For the video version of this episode, please watch on the RQM+ LinkedIn page or Spotify.
For information about how RQM+ helps clients in these areas:
➕ CERs
➕ PMCF
➕ PMCF Survey Development and Execution
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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Our MedTech Voices 10 minutes or less video/audio series, returns with the first of two new clips in a mini series entitled Traversing the Path from CER to PMCF – Clinician Perspective. These two clips will combine clinician and notified body perspectives to share information that will help you avoid errors when approaching your PMCF activities.
Featured experts with LinkedIn profile links:
👩⚕️ Sally Sennitt, M.D. – Medical Director
👨⚕️ Andreas Tarnaris M.D. – Medical Director
👨💼 Jaishankar Kutty, Ph.D. – Vice President of Intelligence and Innovation
For the video version of this episode, please watch on the RQM+ LinkedIn page or Spotify.
For information about how RQM+ helps clients in these areas:
➕ CERs
➕ PMCF
➕ PMCF Survey Development and Execution
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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This show was recorded 23 March 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center.
Artificial Intelligence (AI) has the potential to revolutionize healthcare and the medical technology industry, with the ability to assist in clinical decision-making, improve patient outcomes, accelerate speed to market and improve efficiency. In this RQM+ Live! show, leaders from RQM+ and Giotto.ai will explore the current and future applications of AI in MedTech, including the use of AI in medical imaging, diagnostics, personalized medicine, remote patient monitoring and medical writing. They will also share their insights on the challenges they've experienced so far in the field, and how AI can help solve some of the hardest problems facing the healthcare industry.
This session is designed to be educational and conversational, so please come prepared with questions! The goal of this session is to talk openly and generate ideas about how AI can best benefit you and your organization, now and in the future. We predict companies in the MedTech space who successfully harness AI/ML will have a significant advantage over those that do not.
Panelists:
- Alaric Jackson, Chief Digital and Technology Officer – RQM+
- Amie Smirthwaite, BEng, Ph.D., Senior Vice President, Intelligence & Innovation – RQM+
- Francesco Palma, VP of Product – Giotto.ai
- Wallyson Oliveira, VP of Machine Learning – Giotto.ai
- Celeste Maksim, Chief of Staff – RQM+ (moderator)
Questions with timestamps:
3:07 -- Framing the conversation with definitions... what do these terms mean and how do they differ from automation?
6:50 -- Could you provide examples of how this technology is being used more broadly in life sciences today?
8:40 -- What about from a more specific MedTech perspective?
9:20 -- What about from the industry perspective in general?
10:18 -- How does the transparency and explainability of AI effect its adoption? How can we trust AI?
13:43 -- In a healthcare setting, how are regulators responding to this increased adoption of AI / ML?
14:40 -- If AI is based on pattern recognition, is it possible that when a large amount of misinformation is fed into the algorithm that it causes the AI to make a poor decision? How do you work to prevent this?
16:41 -- What could manufacturers do to leverage AI / ML in their workflows? For example, where do they have large pools of data that could lend itself to using AI / ML to improve the workflows of internal operations or compliance itself?
19:15 -- Once we're thinking about the implementation stage, what are some of the challenges that a manufacturer will encounter along this journey?
23:10 -- What advice would you give a manufacturer in how to approach regulators with a new AI device? Also, do regulators have the necessary expertise from a review perspective?
26:57 -- Regarding data sets, if manufacturers are leveraging consultants or IT groups, how can they work to be sure the data set models are maintainable?
30:57 -- What are you thoughts about AI taking over roles?
36:05 -- How would you avoid bias when using ML and that data?
41:29 -- How would you recommend the listeners get started?
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This is audio from RQM+ Live! #64, recorded 16 February 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Over the past several years the expectations for testing of medical devices per the ISO 10993 standards has significantly changed and continues to change at a rapid pace. Furthermore, different regulatory bodies have different expectations when evaluating this data. Failure to understand these expectations and an inappropriate choice of testing labs can result in product delays and repeat testing.
The expert panel will:
- Describe how chemical characterization, toxicological risk assessment and biological testing work together to evaluate a device
- Explain how to ensure method sensitivity, maximize quantitative accuracy and identification confidence
- Highlight which validation experiments are expected for chemical characterization
- Discuss the major points of departure between European notified bodies and US FDA
- Explain which certifications are necessary for laboratories
- Show how controls used, and when are they necessary in biological testing
- Evaluate how revisions to ISO 10993-17 may impact toxicological risk assessment
Panelists:
- Joel M. Cohen, Sc.D., DABT – Principal, Gradient
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+
- Kevin Rowland – Director of R&D, RQM+
- Taryn Meade – Director of Biological Evaluation Consulting, RQM+
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation, RQM+ (moderator)
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This is audio from RQM+ Live! #63, recorded 26 January 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
The MedTech industry is one of the most heavily regulated industries in the world. The regulatory landscape is changing rapidly and regulations are increasingly more complex.
An efficient and scalable regulatory strategy is now more important than ever. As regulatory bodies worldwide update and enforce regulations at an accelerated pace, the need for speed and flexibility in regulatory functions has never been more critical. The alternatives are failed and damaging regulatory submissions that could ultimately stop a product from coming to market.
In this RQM Live! show, our panelists bring their unique perspectives on the world's largest regulatory markets, the US FDA and EU MDR/IVDR.
Our subject matter experts will:
- Discuss the greatest challenges in regulatory submissions to the FDA and notified bodies
- Provide advice on how to overcome these challenges
- Identify synergies and differences between EU and US regulators
- Provide top tips for successful product submissions and interaction with EU/US regulators
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation
- Carlos Galamba, MSc – Vice President, Intelligence & Innovation - IVD
- Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation
- Jon Gimbel, Ph.D. - Vice President, Technical
Questions with timestamps:
4:22 -- So much has changed over the past few years. Let's discuss how much of a jump it's been for the European market compared to a few years ago and what that means for the FDA side?
9:40 -- What are the top five things that manufacturers underestimate about these regulatory requirements?
10:34 -- How do you go about gathering and presenting documentation for an MDR compliant submission when your notified body won't communicate their criteria and refuses to offer guidance because they're not consultants?
24:20 -- Considering the differences between the EU and the US, what about some of the synergies between the two?
33:18 -- What updates or advice do you have on the timeline extension on the MDR and IVDR?
37:05 -- Are they extending the MDD certifications?
41:48 -- If our MDD certificate expiries in March 2024, wouldn't it need a new date at that point to sell from that day until the MDR certification is obtained? It could take two years until that point...
45:40 -- In relation to the MDD/MDR transition period, for elements like standards, where there may be a difference between the MDD harmonized version and the MDR harmonized version, how should manufacturers handle compliance to older versions for MDD when we are trying to transition to the State of the Art harmonized versions for MDR.
49:02 -- There seems to be a strong incentive to not be novel. Do you see companies underplaying novelty and is there a risk to this?
53:21 -- The end of life of our device that is no longer manufactured is planned for 2027 or 2028. Do we have to pursue MDR certification?
54:55 -- What is your experience with the use of off-label data (while supporting the safety and performance of a medical device) for CE-mark?
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Our PMCF trio is back with another #MedTechVoices clip.
Mini series: ⚙️ 𝐏𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐏𝐌𝐂𝐅 𝐃𝐚𝐭𝐚 𝐰𝐢𝐭𝐡 𝐄𝐜𝐨𝐧𝐨𝐦𝐲 𝐚𝐧𝐝 𝐄𝐱𝐩𝐞𝐝𝐢𝐞𝐧𝐜𝐲
In this episode, Jaishankar Kutty, Ph.D., Niki Caporali Spaniel, RAC and Torrie DeGennaro explore the path from CER to PMCF plan (regulatory perspective).
We hope you enjoy!
The PMCF mini series at a glance:
🔑 1. Focused on notified body feedback and key learnings (find the podcast episode or watch on LinkedIn)
📝 2. Sufficient quality and quantity of clinical evidence (find the podcast episode or watch on LinkedIn)
👣 3. Path from CER to PMCF plan (regulatory perspective)
⚕️ 4. Path from CER to PMCF plan (with medical directors)
🔎 5.+ Deep dive into PMCF plans and outcomes on a per device basis
For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.
For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center. We have a ton of fantastic on-demand content available.
Thank you for listening! We hope you enjoy.
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Our PMCF trio is back with another #MedTechVoices clip!
Mini series: ⚙️ 𝐏𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐏𝐌𝐂𝐅 𝐃𝐚𝐭𝐚 𝐰𝐢𝐭𝐡 𝐄𝐜𝐨𝐧𝐨𝐦𝐲 𝐚𝐧𝐝 𝐄𝐱𝐩𝐞𝐝𝐢𝐞𝐧𝐜𝐲
In this episode, Jaishankar Kutty, Ph.D., Niki Caporali Spaniel, RAC and Torrie DeGennaro dive into sufficient quality and quantity of clinical evidence.
We hope you enjoy!
The PMCF mini series at a glance:
🔑 1. Focused on notified body feedback and key learnings (find the podcast episode or watch on LinkedIn)
📝 2. Sufficient quality and quantity of clinical evidence (this one!)
👣 3. Path from CER to PMCF plan (regulatory perspective) (already recorded and coming next week)
⚕️ 4. Path from CER to PMCF plan (with medical directors)
🔎 5.+ Deep dive into PMCF plans and outcomes on a per device basis
For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.
For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center. We have a ton of fantastic on-demand content available.
Thank you for listening! We hope you enjoy.
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MedTechVoices 🗣️ continues in 2023 with Vice President of Intelligence & Innovation, Jaishankar Kutty, who shares additional thoughts on the EU MDR postponement.
Here are some key takeaways from today's MDCG proposal to amend the transition timelines for medical devices and IVDs:
- The new transition timeline for high risk medical devices (i.e. class III and IIb implantables) is now 31 December 2027
- For medium and lower risk devices, it's 31 December 2028
- For class III custom made devices it's 26 May 2026
In order to benefit from this extension, manufacturers cannot make any significant changes to the device and must have an MDR-complaint QMS by 26 May 2024. An application must be made to a notified body by 26 May 2024 and be accepted by the notified body by 26 September 2024. The benefit-risk profile of the device must also remain unchanged. No certificate expiration date updates by the notified body will be required and periodic surveillance activities by notified bodies will continue.
This timeline extension is to allow safe medical devices to stay on the market. Also, the removal of the sell-off date is to ensure warehouses in the EU are adequately stocked.
The expectation is that your MDR-preparedness is well underway. This proposal by the MDCG is expected to be voted on by the European Parliament very soon.
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For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.
For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center here.
Thank you for listening!
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MedTechVoices continues with the first episode of a brand new mini series: Proactive PMCF Data with Economy and Expediency (#1).
This series is about looking at the successes that RQM+ has had over time in collecting data of sufficient quality and quantity for legacy devices across all device classifications... and sharing our learnings and strategies along the way.
For the first video/audio, Jaishankar Kutty, Ph.D. is joined by Niki Caporali Spaniel, RAC and Torrie DeGennaro.
Our current plan for future episodes in this mini series:
- Focused on notified body feedback and key learnings
- Path from CER to PMCF plan (regulatory perspective)
- Path from CER to PMCF plan (clinicians perspective)
- Exploring some vital parameters that ensure we collect sufficient quality and quantity of clinical evidence
- Deep dive into PMCF plans and outcomes on a per device basis
For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.
For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center. We have a ton of fantastic on-demand content available.
Thank you for listening! We hope you enjoy.
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MedTechVoices 🗣️ continues with Vice President of Intelligence & Innovation, Jaishankar Kutty, who shares his thoughts on the EU MDR postponement.
Earlier today, in the EPSCO meeting, all EU member states unanimously agreed to the proposal recommendations listed below. Belgium asked for a detailed root cause analyses of why the MDR roll out finds itself where it is today. Malta has asked for one single date as opposed to a staggered one based on classifications. There will be a legislative vote on this item in early 2023 with aspects of the MDR to be reviewed/amended by the 2027/2028 timeframe. The MDCG group will generate a new guidance document outlining the details of the postponement.
What We Know Now
In the interest of continued medical device availability and patient safety in the EU, France, Germany, and Ireland proposed the following:
- Extension of the transition period to 2027 for Class III and IIb, and to 2028 for Class IIa and I
- Extension of validity of MDD and AIMDD certificates to suit the aforementioned
- Extensions only apply if no safety signals from PMS data, notified body application for conformity assessment in place before May 2024 and/or QMS certified to MDD by May 2024
What's Next?
While we welcome the postponement, it does beg some questions. If this is done in the interest of patient safety and if the authorities are happy with the safety of devices currently out there and the regulatory mechanism by which they are out there ensuring patient safety, what’s the point of the MDR after all? Also, why the postponement to 2027/2028? Why not any later? What credible data validates the 2027/2028 timeframe? What ensures we won’t be in the same boat, come 2027/2028? We’ve all heard rumblings about stifling innovation and preventing good products from getting to patients. How will the MDR prevent this unless there is a complete re-write instead of a Band-Aid approach?
In the meantime, the notified bodies will most likely pursue the following items:
- Deploy a mechanism for MDD/AIMDD certificate extensions
- Technical file reviews per the sampling plan
- QMS audits per the typical audit cycle
- Unannounced audits will likely re-start/continue
- PMS reports to monitor any safety signals
Importantly, it will be imperative for manufacturers to conduct PMCF studies to gather further evidence to support all indications ahead of the new deadlines.
For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.
For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center here.
Thank you for listening!
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We're back with our second ever episode of #MedTechVoices 🗣️
MedTechVoices is our ongoing video/audio series that provides an avenue for our seasoned, industry-leading experts to share their thoughts and advice when inspiration strikes... and in 10 minutes or less.
Whenever you see a podcast title beginning with "#MedTechVoices," you can expect a podcast 10 minutes or less.
This episode is our second in a series of eight named, "EU MDR expert panel feedback... let it sink in." This clip is focused on the first expert panel opinion published on a Class III implantable device, which happens to be a bone graph intended for maxillofacial surgeries.
If you're:
- Preparing your MDR documentation
- Planning to submit it and are almost there
- Wondering if the need for sufficient clinical evidence is real
Throughout this particular series, Andreas Tarnaris, M.D. and Jaishankar Kutty, Ph.D. will offer unique perspective on the expert panel feedback (CECP per EU MDR, Article 54) on clinical reviews that have been completed over the last year.
For non-Spotify users interested in the video version of this episode, you can view on the RQM+ LinkedIn page here.
Thank you for listening! See more content like this in the Knowledge Center at RQMplus.com.
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We'd like to introduce you to something new: #MedTechVoices 🗣️
MedTechVoices will be our ongoing video/audio series that provides an avenue for our seasoned, industry-leading experts to share their thoughts and advice when inspiration strikes... and in 10 minutes or less.
Whenever you see a podcast title beginning with "#MedTechVoices," you can expect a podcast 10 minutes or less.
Our debut episode is the first in a series of eight named, "EU MDR expert panel feedback... let it sink in."
If you're:
- Preparing your MDR documentation
- Planning to submit it and are almost there
- Wondering if the need for sufficient clinical evidence is real
Andreas Tarnaris, M.D. and Jaishankar Kutty, Ph.D. will offer unique perspective on the expert panel feedback (CECP per EU MDR, Article 54) on clinical reviews that have been completed over the last year.
For non-Spotify users interested in the video version of this episode, you can view on the RQM+ LinkedIn page here.
Thank you for listening! See more content like this in the Knowledge Center at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is audio from RQM+ Live! #62, recorded 3 November, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Most of us have used standards in some shape or form. There are those that assume they know all about standards, and those who think, “Ugh, standards are so boring.” Yet, how many people actually love standards? How many people always ask, “Is there a standard for this?” We do at RQM+.
The consideration and application of standards is a foundational element across the majority of MedTech product lifecycle activities and can provide a clear route to compliance when used well.
Our panelists will discuss key elements of implementing standards and shine light on dark and often misunderstood corners of the world of standards.
Elements discussed include:
- What do we mean when we talk about standards?
- What is the difference between state of the art and the standard of care?
- Where do standards belong within the regulatory ecosystem?
- How can we use standards effectively throughout the product lifecycle?
Panelists:
- Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Carlos Galamba, MSc – Vice President, Intelligence & Innovation - IVD
- Sally Sennitt, MBBS, FRCA – Medical Director
- Ed Ball, CEng MIPEM MIMMM – Intelligence & Strategic Execution Manager
- Rem Siekmann, CMDA, RAC – Senior Principal Engineer/Auditor
Questions with timestamps:
3:42 -- Brief introduction and what do we mean by State of the Art?
12:25 -- How do you establish State of the Art? Should we not create a State of the Art generic standard that recommends companies look elsewhere for State of the Art? Standards, common specifications, trends, etc.
16:37 -- How do you establish what expected outcomes, performance, or design specifications for a product?
21:04 -- Standard of care can usually lag behind technology and practical clinical development. For example, NICE guidelines defines success in hip replacements as a revision rate of 5% or less at 10 years, however, the best prosthesis usually have revision rates of 1-2% at the same stage. Shouldn't state of the art be defined in this case as the gold standard rather than pull towards the average?
29:55 -- When you say stratify by patient population what are the variables we should stratify by? Is it by patient population age, existing health condition, etc.?
33:35 -- What are you seeing in terms of requirements from notified bodies? Are you seeing consistencies or best practices?
43:06 -- How is the State of the Art defined for SaMD/MDSW, especially those without a specific clinical indication (e.g. Class A IVD SaMD)?
46:36 -- For clinical evaluation of custom made (vascular) devices, does it make sense to compare to SotA data on alternative treatments to confirm safety and performance? Considering alternative treatments have generally be ruled out for these patients if a custom made device is being considered.
55:14 -- How do you suggest to approach areas with several standards/guidances published addressing things that more or less overlap - e.g. cybersecurity?
1:00:48 -- What is your best tip or your best piece of advice?
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This is audio from RQM+ Live! #61, recorded 13 October, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Each year RQM+ supports hundreds of FDA 510(k)'s and EU technical documentation files for either medical devices containing software or stand-alone software devices. In this show our regulatory experts will discuss both FDA and EU deficiencies and additional information requests associated with software (real case studies), as well as best practices and solutions to avoid these pain points in your submissions.
- Devices and challenges discussed included:
- Artificial Intelligence (AI) machine learning and acceptability of change control plans
- Defining proprietary algorithms and controlling changes in those algorithms
- Cybersecurity implementation and alignment with ISO 14971 (Risk management)
- Lack of information on connected devices
- Aligning terminology and documentation across various requirements and processes (AGILE, ISO 62304, QSR, MDR, IVDR)
- Off-the-shelf software and expectations for verification and validation testing.
Panelists:
- Allison Komiyama, Ph.D., RAC - Regulatory Consultant at RQM+ and former President and Founder of AcKRS
- Kevin Go, MBA, RAC, CQA - Senior Principal, Regulatory and Quality Practice, RQM+
- Hrishkesh Gadagkar - Principal Engineer, RQM+
Questions with timestamps:
2:55 -- Setting the scene with definitions... what is software as a medical device and how is it defined between the EU and the United States?
3:54 -- What are the main challenges of software from a demonstration of compliance / regulatory perspective? 9:04 -- What are some best practices for creating software documents to avoid deficiencies?
12:21 -- What are you seeing? Are you seeing significant differences between what the EU and FDA are asking for?
18:29 -- What are the regulation standards and documentation requirements for cybersecurity?
23:51 -- If software developers define user stories as their starting point, are additional dedicated software requirements needed?
26:48 -- We are talking about what is needed to make notified bodies or FDA happy... however, the killer point is getting the software engineers into a practical management of requirements, unit, integration testing, etc.
37:00: -- Does a manufacturer need to audit its cloud provider?
39:00 -- Regarding the responsibilities, when a software device is sold and installed in a hospital or a clinical institute, if the software device is disconnected from the Internet and could not perform the functions as designed, who should be responsible for the impact on the patient? The hospital or the manufacturer? Same question: what if the device was hacked?
43:25 -- You just mentioned the connection between SRS and SDS... is traceability between requirements and design critical in your opinion? It seems desirable as it helps add clarity and understanding for the reviewer but also relative to the quality of the design process. Traceability to verification (requirements to verification) is critical, but wondering about requirement to design.
46:24 -- What have you been seeing with AI and machine learning?
52:50 -- What about wearables and AI / machine learning?
55:42 -- Do you have a final piece of advice for our listeners or top tip?
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This is audio from RQM+ Live! #60, recorded 22 September, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Several RQM+ industry leaders contributed to this year's program at the RAPS Convergence in Phoenix, and we’re ready to share what we learned — and what surprised us — from the event. We also answer your questions in the process!
This RQM+ Live! show discusses the biggest takeaways and surprises from this year's RAPS Convergence. We cover at least a little bit of the subject matter in each of our speaker's sessions, including:
- Clinical evaluation
- Recent developments in EU Regulations (MDR and IVDR)
- Post-market clinical follow-up (PMCF) and risk management
- Developing IVDR-compliant intended purpose statements that serve the business and meet notified body expectations
- How to efficiently prepare your eSTAR submission
Panelists:
- Jaishankar (Jai) Kutty, Ph.D. – Vice President , Intelligence & Innovation
- Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation
- Celeste Maksim, Ph.D., RAC – Chief of Staff
- Anike Freeman, M.Eng., PMP – Principal Consultant
- Nancy Morrison, RAC (moderator) – Vice President, Intelligence & Innovation
Questions with timestamps:
3:34 -- Please let the audience know what you spoke about and any key takeaways from the session?
9:24 -- This being the first year back in person after being virtual and hybrid, what did you observe about this conference? What about the attendees?
13:54 -- What was the most unexpecting thing or key learning that you took away from the conference?
24:24 -- Have you also discussed how clinical data and endpoints should be defined when a legacy device has an equivalent device that is now a similar device under MDR, where the legacy device has not yet been placed on the market?
26:27 -- What are we seeing in clinical trials?
28:08 -- What did you hear about surveys?
30:07 -- Am I going to get specifics about my type of device at this conference? Carlos, can you speak to IVD aspect?
33:29 -- How about on the device side... were there a good range of topics and product types represented on the Convergence agenda?
36:38 -- Is it a study if it's a retro chart review that collects personal health information?
40:04 -- What were your takeaways in terms of what's on people's minds and what's bothering manufacturers right now?
42:21 -- What's new with digital health?
43:53 -- How about companion diagnostics?
48:04 -- Did you hear any conflicting advice or things that you did not agree with?
55:08 -- Where is next year's conference?
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This is audio from RQM+ Live! #59, recorded 21 July, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website. To view the list of questions asked
MDCG 2022-2 was intended to provide guidance on how to demonstrate clinical evidence, however we continue to receive so many questions and requests for support around this topic. The concept that clinical evidence is not clinical performance can still be hard for manufacturers to get their heads around, especially considering the cost and effort it will take to demonstrate clinical evidence.
We discuss:
- Differences between clinical evidence and clinical performance, and where we see manufactures struggle
- Notified body expectations and what they will not allow to pass
- Steps to generating data that will be accepted by the notified bodies, and our lessons learned so far; and
- Challenges and guidance on generating clinical evidence for specific IVDs, like general use devices and instruments
Panelists:
- Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation
- Heike Möhlig-Zuttermeister, Ph.D. – Vice President of IVD Intelligence & Innovation
- Bethany Chung, Ph.D., RAC – Principal Regulatory Scientist
- Ron Sills – Senior Principal Specialist
Timestamps:
3:33 -- What exactly is clinical evidence under IVDR and how much of it is a jump compared to the IVD directive?
7:44 -- We're getting a lot of questions related to clinical evidence and it seems to be what everyone is talking about - why is this such a hot topic?
21:32 -- For CDx, if clinical trial with the US test site and EU collection site the device won't be used anywhere except the US, do we have to register with a competent authority?
22:33 -- If a method comparison should not be considered as a clinical performance study, can you define clinical performance study? What is expected in terms of sample sources and sites for a clinical performance study?
26:32 -- How should manufacturers demonstrate clinical performance under the IVDR?
32:58 -- Our experience with NB other data source is only supporting data but peer reviewed lit and routine diagnostic data can be used. [panelists discuss]
34:07 -- How many patient samples need to be tested for Class C IVD test for IVDR clinical performance?
35:26 -- Any comments related to the clinical performance and evidence monitoring, especially during electromagnetic capability testing under 60601.
36:45 -- Could you please expand a bit on EQI schemes?
39:30 -- How often do you have to update PMPF?
41:37 -- Problem: legacy device (class III, implantable) never implanted to date; start of registry (register) with CRO in 08/2022 but no clinical study running. [panelists discuss]
43:13 -- What would you say the highlights were in the MDCG clinical evidence guidance that was published in the beginning of the year for IVDs?
49:30 -- In order to establish clinical evidence for blood IVD assay, we are struggling to find a laboratory medicine standard on what accuracy is required for a specific analyte (e.g. cholesterol). Suggestions?
52:16 -- How does physically moving device production from one facility to another impact IVDR registration or existing 510(k)s.
53:07 -- Can we quantify benefits for IVD? We currently do a qualitative assessment.
54:45 -- What is required to demonstrate State of the Art for IVDs?
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This is audio from RQM+ Live! #58, recorded 14 July, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Companion diagnostics (CDx) are critical to patient safety when taking potentially life-saving drugs, e.g. in oncology. CDx can help identify which patients will benefit from a specific drug treatment to improve patient outcomes and identify those patients who have an increased risk for serious side effects from a certain treatment. Hence, CDx are essential in the evolution of precision medicine “providing the right therapy to the right person and the right time” and helps tackle rising healthcare costs, by minimizing drug use to only those who will definitely benefit from a drug.
CDx is an in-vitro diagnostic medical device which are governed by the IVDR in Europe and need to undergo a CE-marking process with a Notified Body to place the CDx on the market. The CE-marking conformity assessment includes a separate consultation procedure between the NB and a medical authority, depending on who is responsible for the authorization of the corresponding medicinal product.
The regulatory framework for drugs and CDx (IVDs) in Europe are governed by two different European legislations with separate registrars. The terminology of these two legislations is not fully aligned which leads to confusion across all stakeholders, the medicinal agencies, the Notified Bodies and the CDx manufacturer. A notified body working group on CDx has taken on this challenge, trying to align multiple notified bodies and the European Medicines Agency (EMA) on the expectations for CDx.
Our expert panel includes TÜV Rheinland’s CDx Teamlead Rolf Thermann, who is also the leader of the notified body CDx working group. Rolf’s role includes building a successful team of experts for auditing and certification of CDx manufacturers, interacting with key opinion leaders in the field of personalized medicine/CDx and establishing communication channels with relevant authorities. In this show, we discuss areas of confusion in industry and notified bodies, and what manufacturers can expect, including:
- Where is the line between a CDx and a non-CDx IVD?
- What data is required for CDx approval for both scenarios: CDx co-developed with the drug, or a follow-on companion diagnostic?
- What does the consultation process between the notified body and the EMA look like?
- Why do manufacturers need to do double work in the approval process? The manufacturer pays for EMA to review both the drug and CDx, but EMA only provides approval for the drug. Then the manufacturer must pay the notified body and again EMA to review and assess the CDX to obtain specific CDx approval from the notified body.
We’ll kick off this panel discussion with a brief presentation by CDx expert Rolf Thermann. Our panel also includes Heike Moehlig-Zuttermeister and Carlos Galamba – both of whom are RQM+ VPs of Intelligence & Innovation, and former BSI IVD Technical Team Managers and IVDR implementation leaders. Heike and Carlos are now working on the consulting side of industry, supporting manufacturers with challenging IVDR submissions.
Panelists:
- Rolf Thermann, Ph.D. – Teamleader Companion Diagnostics, TÜV Rheinland
- Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation, RQM+
- Heike Möhlig-Zuttermeister, Ph.D. – Vice President of IVD Intelligence & Innovation, RQM+
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This is audio from RQM+ Live! #57, recorded 30 June, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
At RQM+ we're often asked about the FDA appeals process and if it's worth the effort and perceived consequences. The thought of going head-to-head with FDA is intimidating, especially to small medical device companies trying for their first product clearance/approval.
Our panelists recently supported a client with the appeals process and successfully overturned FDA's NSE (Not Substantially Equivalent) determination, so they bring incredibly fresh insight on the process. These panelists include a former FDA CDRH rep who worked on appeals from the FDA side, as well as Mark DuVal of DuVal & Associates, PA: a law practice with a truly excellent success rate in FDA appeals.
Our Live! show discussion will include:
- Case study of a successful appeal
- What does the appeals process really look like?
- Will an appeal damage your relationship with FDA?
- What scenarios are good candidates for an appeal?
- Why are appeals increasing?
- Stories of wins and losses
Panelists:
- Mark DuVal, J.D. FRAPS – President, DuVal & Associates, PA
- Daniel Clark – President/COO/Co-Founder, Linear Health Sciences
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services, RQM+
- Kevin Go – Project Engineer, RAC (former FDA CDRH Lead Reviewer), RQM+
Timestamps:
3:07 -- Dan, this is your story. Could you give us the highlights?
8:37 -- [Mark takes over]
13:23 -- [Mark discusses clinical position]
14:55 -- [More outlining of lengths Linear had to go through to accomplish this]
20:29 -- Besides technical issues, did you have any administrative problems?
24:30 -- Was Linear's experience typical or does this look different than most of your appeals?
26:46 -- Do most startups fold long before this?
28:19 -- What's it like on the FDA side of these appeals?
30:34 -- Is there insight you can provide to those listening? How as a sponsor can we get to those dialogues?
35:47 -- How does FDA feel when they're being challenged in these appeals?
40:20 -- Is everyone even talking? Does it matter that there are 483s in one division and another division is doing an appeal?
41:33 -- What are some scenarios that are good candidates for an appeal?
47:12 -- Are you see an increase in appeals?
53:03 -- We submitted a Pre-sub and it took 10 months for a response (after they changed the date 3 times) and when we got the feedback the questions weren't even answered just pointed to guidance docs and no opportunity to discuss the feedback as an option provided.
54:10 -- What recommendations would you have for FDA to provide the PhD graduates with the appropriate regulatory perspective? How might the industry help FDA?
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This is audio from RQM+ Live! #56, recorded 9 June, 2022. To join us live for future shows and ask your own questions, please view and register for upcoming sessions in the Knowledge Center at our website.
RQM+ is bringing together expertise from the world’s largest notified bodies, TÜV SÜD and BSI, to discuss IVDR implementation challenges and lessons learned so far. A lot has happened since October 2020, when notified bodies issued the first IVDR certificates.
In this session we will discuss:
- Notified body feedback in several areas from intended purpose, clinical evidence, and post-market surveillance requirements
- Lessons learned from the IVDR application process
- Expectations and the increased scrutiny mechanism for Class D devices
- Notified body resource challenges and impact on certification timelines
- How to prepare for the future of the IVDR and adapt their transition strategy accordingly
Our three featured panelists are:
- Marta Carnielli, Pharm D – IVD Technical Director, TÜV SÜD
- Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation, RQM+
- Heike Möhlig-Zuttermeister, Ph.D. – Vice President of IVD Intelligence & Innovation, RQM+
Questions:
3:10 -- How did you end up working in the diagnostics sector and what is your role at the notified body?
21:36 -- With only seven notified bodies designated so far, capacity issues seem to be ongoing. Do you see changes coming?
32:01 -- Let's talk about the application process in more detail... we're finding many manufacturers are struggling with this process - can you tell us some of the main issues notified bodies are seeing?
42:18 -- How can we be compliant as much as we can if the notified bodies don't know how to be compliant?
44:44 -- Let's talk about conformity assessment: once the manufacturer completes their application, what are the next steps and how long will it take before the file gets reviewed and they can expect a certificate?
50:25 -- How are you dealing with virtual manufacturers?
59:28 -- For Class D devices, we are not aware that any IVDR certificates have been issues yet for high risk devices. When can we expect the first one to be issued?
1:02:19 -- Do you have any final recommendations for our audience as they prepare for IVDR?
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This is the audio from RQM+ Live! #55, recorded 19 May, 2022. Listen and learn why the MDR / IVDR labeling requirements are a great opportunity to start with a blank slate and achieve global market compliance.
Medical device and IVD labeling has always been a challenge for manufacturers because updates are often required when new regulations are introduced. With the piecemeal approach that is commonly taken, the result is a product box covered in labels or inconsistent language and placement across product lines. This can be confusing and overwhelming for end users.
With the implementation of MDR and IVDR requiring significant labeling revisions, manufacturers should consider it an opportunity to start with a blank slate to both achieve global market compliance and eliminate duplicate and inconsistent information.
The reality is that labels will always need to be updated, and manufacturers need processes and systems for:
- Updating labels based on regulatory and customer requirements
- Keeping track of label changes for all products
- Assessing global impact to label changes
- Determining when to do a comprehensive label assessment
- Implementing label changes that follow best practices
- Creating new labels after an acquisition or merger
- How to respond when an error is found
Led by global regulatory experts with more than 25 years of experience, this show will discuss how to start over with labeling and create a streamlined process for future updates. By making an investment now, manufacturers will see long-term benefits, such as minimizing the impact of future updates and better streamlining for managing large-scale changes.
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Kevin Go – Project Engineer, RAC (former FDA CDRH Lead Reviewer)
- Laurie Petit, PMP – Principal Advisor
Questions:
2:35 -- What do we mean by labeling?
3:48 -- What kind of issues are you seeing, especially resulting from MDR implementation and the new labeling considerations?
9:31 -- Does labeling expand into the website content?
12:34 -- As long as your labeling is compliant, why should anyone care and consider starting from scratch?
23:04 -- Can we still supply our product with the same CMD labeling until the conformity assessment is completed or should we change our labeling?
24:18 -- Say I believe that I could save money and heartache in the long run if I overhaul my labeling... where do I start and what are some best practices?
29:06 -- Do you find that people are confused about what's really required?
38:16 -- Thinking globally, if I have to put the names and addresses of the local authorized reps for all of the countries on the label for my software device, is it compliant to put only a URL on a label that links to a website with all my ARs?
40:08 -- How far away are we from utilizing barcoding to cover common symbology translations and also legal manufacturer and economic operator addresses where there will be several to include in the UK, EU, and Switzerland importation.
41:43 -- In the EU, since we are using symbols from ISO 15223 which is harmonized under MDR, no symbol glossary is needed in the IFU. Can we supply this same IFU to the US without the symbol glossary?
45:36 -- How do you overcome labeling requirements for products that are small in size?
47:49 -- What are the types of products or scenarios where you'd say, it's time... it's time to overhaul my labeling?
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This is the audio from RQM+ Live! #54, recorded 5 May, 2022. Listen as our panelists provide insight on the changes in the new requirements and what steps companies should take to update their quality system.
FDA requires companies to conform to the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR 820). However, many other international regulatory authorities require compliance to the internationally recognized regulatory requirements of ISO 13485.
This misalignment has created extra challenges for companies who market devices in multiple countries, as they have to meet two different sets of requirements. After many years of effort, including participation in the Medical Device Single Audit Program (MDSAP), FDA has released a proposed rule to amend the CGMP requirements of the QS Regulation to align more closely with ISO 13485:2016. While 21 CFR 820 and ISO 13485:2016 share many requirements, there are various differences regarding risk management principles, quality system record requirements (i.e. Device Master Record, Design History File, Device History Record), labeling and packaging controls and others. While this creates the opportunity to have one quality system to address all country requirements, companies need to update their quality system to ensure it complies with the new requirements.
In this show, subject matter experts including former FDA CDRH representatives provide insight on the changes in the new requirements and what steps companies should be taking to update their quality system.
Panelists:
- Ralph Asencio, MBA, BSME – Vice President of Technical Services
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Richard Freeman, Ph.D. – Director, Global Audit Practice
- Kevin Go – Project Engineer, RAC (former FDA CDRH Lead Reviewer)
Questions:
2:28 -- Is the FDA actually proposing to adopt ISO 13485 or just proposing to be close to it?
4:52 -- Why are they just not adopting it?
6:23 -- What is an overview of the changes to part 820?
8:18 -- In terms of timelines, where is the FDA on its journey of adopting ISO 13485?
10:00 -- Will the FDA keep in lockstep with SIO 13485 updates?
11:10 -- As new technologies come into play, how receptive are they into adopting SaMD lifecycle, requirements and guidance, etc.?
14:18 -- When the two standards are sort of in one, what are the significant changes that manufacturers will observe?
18:10 -- Commentary on MDSAP...
20:21 -- What kind of impact will the change and adoption have on the FDA?
24:30 -- Does all of this allow you to streamline what you have? Can this be a reset button?
26:47 -- What should manufacturers be doing now as we prepare for this transition?
29:17 -- If you're part 820 compliant and have 13485 as certification, are you already compliant with this new initiative?
32:29 -- What would RQM+ do if we were engaged?
33:37 -- Is this just another step in harmonization?
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This is the audio from RQM+ Live! #53, recorded 21 April, 2022. Please note we have not listed the questions asked during the show in this description because there were too many to fit! You can still see a list of them on the video recording page after filling out the form on our website here.
Our Live! discussion topic "PSURs - Ready, Set, Go!" on 24 February had record-breaking attendance, which means scheduling a sequel is a no-brainer. The discussion between the audience and our expert panelists was extremely engaging and could have gone for hours, so we're back for part 2.
It's obvious that industry is very concerned with the upcoming MDR and IVDR deadlines related to PSURs and unfortunately, there is still a lot of uncertainty and confusion. We're here to help! In part 2 of this discussion, we'll begin with audience questions we didn't get to last time, including:
- Do we need the IMDRF coding only for reportable cases or for all complaints coming in and include in the PSUR?
- Do you have any implementation tips to consider across the device lifecycle? What should we think about when building our maintenance program?
- If we have not sold anything commercially, but we do have a system out for clinical study use, do we need to create a PSUR?
- For legacy devices that are no longer sold, therefore not intended to be MDR certified, is the intent that the PSUR/PMSR just be available upon request or does it need to be proactively submitted to the last Notified Body that certified the device?
- Will the PSUR guidance define the length of the reporting period?
- What type, method and level of trending is expected in the PSUR?
- What data should you use for similar devices - literature, registries, any other?
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Celeste Maksim, Ph.D., RAC – Chief of Staff
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About RQM+
RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. We deliver transformative solutions by providing unrivaled collective expertise fueled by our passion for client success. Our team is collaborative, laser-focused on client needs, and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.
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This is the audio from RQM+ Live! #52, recorded 7 April, 2022.
During our previous show on this topic we were flooded with questions from viewers (which we love!) and couldn't answer them all, so we're back for a sequel.
Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge.
Rollover questions we'll kick the discussion off with:
- Have you had any unique or unexpected feedback from notified bodies or FDA? Have you seen misinterpretations by the regulators?
- What is the difference between Physical and/or chemical information vs chemical characterization?
- For reusable devices, has there been any requests for "biocompatibility over the lifetime" per ISO 10993-1:2018, and if so, how is this typically handled?
- Is it necessary to have a toxicologist expert interpreting chemical characterization data?
- What do you do if you have a large number of unknowns in chemical characterization?
- How do you use exemptions for intact skin devices made of common materials (U.S.)?
The panel of subject matter experts, including former FDA CDRH and BSI leaders:
- Jaishankar (Jai) Kutty, Ph.D. - VP, Intelligence & Innovation
- Kevin Go, RAC - Project Engineer (former FDA CDRH Lead Reviewer)
- Lucie Dalet, Ph.D. - Senior Regulatory Specialist
Questions:
2:28 -- Have you had any unique or unexpected feedback from notified bodies or the FDA? Have you seen any misinterpretations?
9:26 -- Does the FDA influx of new staff factor into the micromanaged questioning and more rigorous approach?
13:20 -- Are we seeing any delays because of laboratories being backed up?
16:50 -- Are there trends from the FDA on adopting biocompatibility testing? Is there an uptake for special 510(k) submissions?
18:02 -- Has anyone had FDA pushback on LCMS ionization mode justification ACPI vs. ESI? (more context added throughout question)
23:29 -- Has anyone had any experience with questions on biocompatibility over the lifetime? If the device is reusable, should the cleaning agents be incorporated in the testing as well?
26:57 -- What testing do you recommend to confirm that a suspected cleaning operation doesn’t leave the part with significant contamination; e.g., cleaning off mold release or stainless-steel solder flux?
30:10 -- How are we advising our clients with legacy devices and their approach?
32:44 -- How do you use exemptions for intact skin devices made of common materials (U.S.)?
36:58 -- Differences between physical and/or chemical information vs. chemical characterization... what are your thoughts?
39:40 -- What do you do if you have a large number of unknowns in chemical characterization?
41:20 -- What about devices that are compatible with chemical characterization?
43:30 -- Do the manufacturers need to provide any evidence for their CrCo device whether the cancer and death cases reported in their PMS are not related to Cobalt content in the device?
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This is the audio from RQM+ Live! #51, recorded 24 March, 2022.
In this session, our panel of clinicians (including a neurosurgeon and anesthesiologist) will discuss ways that they work with regulatory affairs teams to improve outcomes for submissions, including the following:
- Scoping intended use/purpose and clinical indications (incorrect scoping is currently the biggest issue notified bodies are findings in IVDR submissions)
- Scoping state of the art from a physician's perspective, ensuring it truly represents what clinicians do on a daily basis
- Identifying clinical risks and mitigations clearly across risk, CER/PER and PMCF/PMPF documentation
- Clearly defining the clinical roadmap for ease of understanding and review
- Writing CERs/PERs that are comprehensive and will withstand review by clinical experts in regulatory authorities
- Responding to post market surveillance challenges
- Reviewing claims and guiding responsible marketing
- Being part of cross-functional teams from device development through the entire device lifecycle
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Sally Sennitt, MBBS, FRCA – Medical Director
- Andrew Tarnaris, M.D. MD(Res) FRCS(NeuroSurg) – Medical Director
- Dulciana Chan, M.S.E. – Principal Consultant
Questions:
1:50 -- What are the areas of the regulatory process where you think we could be leveraging medical directors more?
5:23 -- Have you found other reasons why else it is important to involve clinicians in your submission process?
10:18 -- As an FDA reviewer (to Dulciana), could you see submissions that involve clinicians vs. not, or where intended use is off-base?
11:03 -- Do you think there is going to be a problem with titling these indications, and therefore... clinicians being used to their old ways... using devices almost off label?
14:47 -- How can you include your external medical experts in your QMS processes and training to be able to participate in an organization's procedures for risk management and clinical evaluation?
17:27 -- Scoping State of the Art has been a huge challenge. How could clinicians help with that?
23:07 -- Can you use the designing surgeons to be part of the process?
27:37 -- One process for early understanding of the level of clinical data needed for MDR certification is through ‘proposed clinical path review’ by the NB. But the same NB glut and delays observed for cert. are similar for this vehicle (NB clinicians appear to be too busy with cert. to even address clinical path review). Are there other approaches for companies to understand what level of clinical evidence is needed prior to submission of a full application?
39:57 -- Could you enlighten us on where the border between consulting and providing information stands?
41:57 -- Where is that line when it comes to FDA?
44:25 -- What's your opinion on software as a medical device, trends on classification, and how to take help from clinicians for scoping?
47:36 -- What about CERs and PERs, specifically?
52:30 -- Are there any key takeaways to wrap up? (includes commentary on PMCF and an overall summary)
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This is the audio from RQM+ Live! #50, recorded 10 March, 2022.
A "notified body application" for IVDR CE certification can feel like 510(k) submission to IVD manufacturers who are new to the notified body relationship. Notified bodies are quoting a range of < 1month to 6+ months review time based upon application quality. Per the notified bodies, the majority of applications have problems, so a 6+ month review time is currently the norm.
Errors and deficiencies are commonly found in the intended purpose, classification, code assignments, acceptability of product groupings, and verification and description of activities of suppliers, subcontractors, and manufacturing sites.
In this Live! show featuring former notified body representatives fresh out of their IVDR leadership roles, we'll discuss best practices for delivering accurate and compliant applications that will be reviewed efficiently, and accepted by the notified bodies.
Panelists:
- Heike Möhlig-Zuttermeister, Ph.D. – Vice President of IVD Intelligence & Innovation
- Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Felicia Hosey, RAC – Principal Advisor
Questions:
2:35 -- Let's define the term notified body application and ask... why is it an important step of the process?
8:51 -- Is the application the same for all notified bodies?
11:39 -- When should manufacturers start the application process?
19:18 -- What are the key components that are part of the notified body application?
34:43 -- If we need a brand new device certification from a notified body we've never worked with before, the process starts first by contacting them on the website and then the application process starts... what does that look like? What kind of documentation is required when you think about the application process versus just contacting and shopping for a notified body?
39:47 -- If we're going to launch a novel or innovative IVD in Europe in 2025, when would we need to engage a notified body?
44:52 -- Let's talk about pricing... can we negotiate our pricing? What does this proposal really mean? What exactly are man-hours?
51:06 -- Any final lessons learned or best practices to share with everyone listening?
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This is the audio from RQM+ Live! #49, recorded 24 February, 2022. The session description below has been abbreviated significantly in order to list the questions covered. You can read the full description here.
Whether you've already created PSURs and are looking for ways to optimize and improve, or haven't started yet, you'll want to hear our panel of experts discuss best practices and lessons learned based upon case studies of successes, failures, and notified body feedback so far.
Questions:
2:24 -- What is your experience so far with supporting the industry with PSURs?
3:35 -- Have you had any notified body feedback yet on PSURs?
10:54 -- Is there any news on when the guidance is coming?
12:20 -- What needs to be covered in respect to same/similar to medical devices in PSURs?
14:47 -- Any best practice for implementing expected undesirable side effects to our end process?
16:12 -- What is the team's view on whether a CER should always be updated following an update of the PSUR and what are the different purposes of the PSURs vs. the CER? [link to RQM+ webinar referenced]
18:25 -- When does the first PSUR for medical devices need to be prepared according to EU MDR?
20:35 -- Where are you really seeing manufacturers first struggle? Where's that first hurdle?
22:47 -- From a notified body perspective, what are people missing in their PSUR programs?
29:14 -- Could you please discuss how the PSUR is related to the PMS Report and PMCF Report? Or all three documents required or can we only provide a PSUR?
30:49 -- What time period should be considered in a PSUR?
31:42 -- The draft PSUR guidance we've seen from MDCG notes the first PSUR being due December 2022 for Class III and IIb. Should this be taken with a grain of salt until guidance is finalized?
33:49 - How should we handle adverse events if our device is very new?
34:28 -- Interesting comment from the audience: their PSUR was inspected onsite in an annual QMS audit in August of 2021 by BSI.
34:48 -- Back to same/similar, when the company itself has same/similar products which are not medical devices, where you would have a lot of information like sales volume complaints as well, should that also be included in the PSUR or is that overload? (reference to mouthwash)
37:14 -- A lot of the information required by PSURs seems redundant to the information contained in the CER for the medical devices. How does this info need to be reported and analyzed differently in the PSUR, if at all.
38:05 -- What happens if there is a lot of clinical data on a similar device that is not marketed anymore in Europe, but it was marketed before? Can we use that data for comparison with our device under evaluation?
39:37 -- How would a manufacturer of a reusable surgical instrument that is categorized as Class IIa calculate a complaint rate for a five-year period when the devices cannot be used beyond the five-year PSUR review period?
40:41 -- In the absence of IMDRF codes for summarizing non-serious incidents, is it acceptable to use internal coding or should internal coding be translated to the applicable IMDRF code?
41:23 -- How soon do you expect notified bodies to require IMDRF coding only for PMS data presentation in PSURs?
41:55 -- How do we select similar devices - can we select a few or should we include all in the PSUR?
42:31 -- Is there any requirement to conduct a technical literature review in the context of the PSUR?
43:06 -- Should benefit-risk analysis be part of the PSUR or CER?
45:55 -- Population using the device - should it be understood as a patient
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This is the audio from RQM+ Live! #48, recorded 10 February, 2022. The session description below has been abbreviated in order to list the questions.
On 26 August, 2021, we conducted a Live! show on the topic of sustaining EU MDR and IVDR, and we were flooded with audience questions... which we loved! We ran out of time and promised a round two to give everyone a chance to pose their questions to our panel of former notified body leaders and industry experts. Five months have passed and our educated guess is you have even more challenges and questions to bring to the table. If you do, our team is ready for them.
While many of you in the device industry have achieved certification for some or all of your products, we know it can be just as big of a challenge to keep up with all the new requirements for post-market reporting and documentation updates. For IVD manufactures, hang on to your hats because as your device colleagues can attest, you have a difficult road ahead and the post-certification phase will not provide much relief.
As always, our RQM+ experts are thrilled to utilize our Live! show platform as a way to knowledge-share across the industry. Please bring your toughest questions and join the discussion because we're here to help!
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Carlos Galamba, MSc - Vice President of IVD Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Jonathan Gimbel, Ph.D. – Executive Director, Technical Leadership, Clinical & Post-Market Practice
Questions:
3:29 -- Summarization of new requirements of the post-market phase (if watching video, includes with graphic)
5:40 -- In preparation for MDR, how long should updating everything actually take and how long is too long?
8:04 -- In preparation for IVDR, how long should updating everything actually take and how long is too long?
8:59 -- Is there an ETA for the MDCG guidance template for PSURs?
10:04 -- Do you believe that EUDAMED when it actually goes live will be a good resource for post-market data in the same vein as MOD when doing updates for the CER and PMCF?
13:44 -- What experience have you seen from the notified bodies for accessing the readability of the SSCPs?
19:09 -- If three months is the suggested timeframe for having most recent data, then how is the RQM+ PMCF completion of 29-32 weeks falling in this schedule? What are the chances the notified body would comment that the data doesn't have value?
21:05 -- What kind of data specifically has to be less than six months old?
24:03 -- Have you had feedback on if deviating from IFU language is acceptable for the SSCP to improve readability to that 14-year-old level?
27:14 -- Our regular moderator Lisa forgets to unmute herself for the first time in the history of RQM+ Live! She had a good run. ;-)
27:24 -- Should MDCG be referenced in the GSPR checklist or rather in the body of the Annex II technical documentation?
29:18 -- Our company believes that resource levels should go down after certification. How do I convey that maintenance in PMS will be intensive? (answered by function)
37:18 -- In September of 2021, BSI did a webinar about PSURs and PMS reporting and stated that data outside the 90-day window was not acceptable. Has that changed?
38:22 -- What is an acceptable frequency for the PMCF literature search activity for different classes of devices?
39:29 -- How much harder is a design change MDR than it was under MDD?
41:17 -- Is a PMCF plan required for Class Is devices?
42:36 -- What do you recommend IVD manufacturers be thinking about or implementing now to be ready for the sustaining phase?
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This is the audio from RQM+ Live! #47, recorded 27 January, 2022. The session description below has been abbreviated in order to list the questions.
The equivalence requirements of MDR Article 61 Sections 4 and 5 have been interpreted conservatively thus far by notified bodies and industry. It's simple – for Class III and implantable devices, the manufacturer cannot leverage data from an equivalent device unless the equivalent device either belongs to that manufacturer or that manufacturer has a contract with the equivalent device's manufacturer allowing access to their data. If those requirements cannot be met, the MDR states that the manufacturer must undertake clinical investigations.
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Jonathan Gimbel, Ph.D. – Executive Director, Technical Leadership, Clinical & Post-Market Practice
- Andrew Tarnaris, M.D. MD(Res) FRCS(NeuroSurg) – Medical Director
Questions:
2:30 -- Amie, you wrote an opinion paper on the equivalence requirements of MDR Article 61. Can you share why you wrote the paper and summarize your points?
5:30 -- Flowchart shown (video recording only)
9:25 -- Was there a specific device you were working on that spurred you to finally write this down?
12:15 -- Are there any other specific devices you have come across where this would be really helpful?
14:24 -- What devices would this not apply to?
23:13 -- How likely do you think it is that notified bodies would accept this? Have you heard any feedback yet?
27:16 -- If a new device is a further development of a current marketed device, is it possible the clinical data for that marketed device to be still applicable for the next generation device without claiming equivalence provided that there are no expected differences in clinical performance?
28:37 -- If two devices belong to the same generic group, does this mean they need to be equivalent?
29:08 -- For MDR, it shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence. Examples of what conditions would satisfy this requirement?
31:39 -- Is it the case that if the company doesn't have access to the technical file of the equivalent device, that the equivalence argument cannot be substantiated even for Class I-11b devices.
32:16 -- A new WET device as defined by the articles such as a plate or pin which is not CE marked under either MDD or MDR that has no equivalent device, the language in 61-6b would initially lead the reader to believe a clinical investigation is not needed. But the caveat is, without an equivalent device or common spec, you can't support the notion that there is sufficient clinical data, thus a clinical investigation is indeed required. Thoughts?
36:37 -- Is it safe to conclude that Article 61-5 is not applicable to Class IIb or lower, in other words, if Class IIb non-implantable can claim equivalence to another manufacturer's device without access to the tech file, that's OK.
37:58 -- If there any change in the design of a device, does it need to go through the same route - I will use the spinal cage as an example - if there is a new design change in shape in the spinal cage, is it considered a new device category or can it go under the spinal cage category?
40:55 -- What do you recommend companies do right now with this new information?
43:23 -- What else will the naysayers say and why are they wrong?
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This is the audio from RQM+ Live! #46, recorded 13 January, 2022.
As we enter 2022, we'd like to reflect on what's happened over the past year in the world of FDA and medical devices. We'll be sharing our insights to how the Agency did in 2021 and a recap of the most important, cross-cutting regulatory changes. Additionally, we'll provide a forecast of what we can expect in 2022.
This discussion will cover the following and more:
- Impact of COVID on FDA resources and submission timelines in 2021
- Updates on breakthrough and new developments for innovative devices, such as the Safer Technologies Program (STeP)
- FDA Process Improvements, including the eSTAR pilot
- FDA 2022 focus areas, including MDUFA V Negotiations expectations and CDRH 2022 Guidance Priorities
The panel of former FDA CDRH and industry subject matter experts:
- Kevin Go – Project Engineer, RAC – RQM+ (former FDA CDRH Lead Reviewer)
- Allison Komiyama, Ph.D., RAC – Former Founder and Principal Consultant, AcKnowledge Regulatory Strategies (now with RQM+)
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services, RQM+
- Bryan Pinder – Project Engineer, RAC – RQM+ (former FDA CDRH Lead Reviewer)
- Ryan Randall – Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer)
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Questions:
3:40 -- What was 2021 like on the inside at FDA?
13:21 -- Could you summarize the updates and changes at FDA in 2021?
14:52 -- Allison, you've worked on many STeP applications - what's been your experience?
20:08 -- Let's talk about the eSTAR program... good, bad, any experience with it so far?
27:21 -- What is new in digital health at FDA?
31:58 -- Are you able to get Q-Sub meetings now?
33:17 -- What's taking up FDA's time? It can't be EUA's, right?
35:37 -- Is there any data on the clearance time using eSTAR? (the answer is no)
36:00 -- How about the status of EUAs... what's going on with them?
40:35 -- Any other impactful changes at FDA that people should be aware of from 2021?
46:47 -- What about biocompatibility?
48:10 -- How about MDUFA?
49:06 -- Any other key things anyone wants to point out before we wrap up?
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Next RQM+ Live! show:
- 27 January: RQM+ Live! #47 — Have we been looking at EU MDR equivalence requirements all wrong?
-
Stay informed:
- See all expert content
- Subscribe to our blog
- Follow us on LinkedIn
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About RQM+
RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.
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This is the audio from RQM+ Live! #45, originally recorded 16 December, 2021.
Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge. In this show, we will discuss the changes to standards in recent years, what’s on the horizon for 2022, and answers to common questions we receive like the following:
- Is the biocompatibility approach different for US and EU?
- When should you consider a chemical characterization approach?
- How do you use exemptions for intact skin devices made of common materials (US)?
- What’s the best process for managing changes to material or manufacturing processes?
- What can you change and still claim equivalence?
- What new developments have there been in 2021?
Here's the esteemed panel of subject matter experts, including former FDA CDRH and BSI leaders:
- Jaishankar (Jai) Kutty, Ph.D. VP, Intelligence & Innovation
- Nancy Morrison, RAC - Executive Director, Regulatory & Quality Consulting Services
- Jonathan Gimbel, PhD - Executive Director, Technical Leadership, Clinical & Post-Market Practice
- Kevin Go - Project Engineer (former FDA CDRH Lead Reviewer)
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Next RQM+ Live! show:
- RQM+ Live! #46, 13 January - Year-end Review and 2022 Outlook on FDA Submissions
Stay informed:
- See all expert content
- Subscribe to our blog
- Follow us on LinkedIn
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About RQM+
RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.
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The RQM+ team has collected PMCF data from surveys on thousands of patients and charts on hundreds of devices, and we're excited to share our case studies. In this Live! show we will dive into our PMCF survey successes and discuss the ways that surveys have significantly helped manufacturers maintain label indications by providing a process for collecting data to support all claims, indications, and user populations. The survey approach has saved our clients significant amounts of money (in the millions) by avoiding the need to remove indications that would cause relabeling and rework of product in the field, or worse, complete removal of the product from the market.
We'll cover the four types of surveys we conduct:
- General user feedback surveys
- General user feedback surveys deployed through a panel
- Patient level surveys
- Retrospective patient chart review conducted via surveys.
Panelists will discuss details to make planning PMCF surveys for your portfolio a success including:
- Realistic survey activity timelines
- Ideal team composition and size
- Regulatory, ethics, and legal considerations
- Using survey data to address notified body review questions
This is a unique opportunity for you to ask questions on the details of what makes these surveys a success and how to apply surveys to your products.
- Celeste Maksim, Ph.D., RAC - Chief of Staff and Moderator
- Jaishankar (Jai) Kutty, Ph.D. VP, Intelligence & Innovation
- Niki Spaniel, RAC - Senior Principal Specialist
- Brian Hockett - Principal Engineer
- Torrie DeGennaro, CBA - Senior Engineer
- Ethan Elshoff - Associate Project Manager
Questions:
3:03 What risk classes of devices have we done surveys for?
3:26 Can the team provide some different types of surveys or styles, and then examples with devices?
4:39 Do you have any example of one of the patient level surveys?
8:15 Have these surveys been submitted to notified bodies? Have they been reviewed successfully? What has your feedback been?
12:23 Can the team elaborate on collecting long-term data via surveys? 14:30 -- Discussion around data quality and ranking the quality of data coming from a survey
18:40 What are some things we've learned about question design? How are you able to obtain meaningful data?
19:43 Bias when it comes to physician surveys: What if people are responding that use the device quite a bit? When doing these surveys and getting responses, if physicians are responding from memory, how is that weighted factual evidence vs. patient charts.
24:43 What do we do to improve the response rate?
26:11 What is a realistic timeline to develop a protocol, deploy a survey, analyze the data, and write a report?
27:36 Some clients don't want to ask certain questions in their survey, like adverse events or emerging risks - how do you handle that?
32:15 For devices not geared towards patient chart review, how do we do surveys for these types of devices? 34:45 - What do you mean by "panel?"
36:03 What are the regulatory requirements for a third party panel?
37:55 How important is translation?
38:43 What are you seeing as the acceptable number of responses?
40:18 For a population-based approach, what if the device has very little sales (less than 100) and it's a Class III product. What would you recommend we do?
43:09 Regarding a Class IIb imaging device... the surrogate endpoint is image quality and there is not a large install base. From a deployment perspective, what do you recommend?
44:48 Do you have any specific device related to surveys for mass market medical devices?
46:36 Any final advice or things we want to leave the audience with today?
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This is the audio from RQM+ Live! #43, originally recorded 11 November, 2021.
MDCG 2021-24: Guidance on Classification of Medical Devices was released in October 2021, clarifying spinal implantable medical device classifications.
Related MDR language published in 2017 left room for interpretation. In the absence of official guidance over the past 4+ years of transitioning to the MDR, manufacturers made the case for IIb classification, which was reinforced in 2018 when Team NB published a position paper stating that many spinal implants are Class IIb since they are wedges. MDCG 2021-24, in conflict with that paper, is setting off alarms across the industry as spinal implant manufacturers come to the realization that they have a lot more Class III devices than they planned for.
What is the impact of class III designation to manufacturers? Will additional data be needed? Will existing clinical evidence be sufficient? Will the increased frequency of CER updates and PMCF reports require more resources?
Join industry's leading experts, including recent notified body leaders and medical experts, for a discussion of these questions along with solutions and next steps you'll want to consider.
The panel will include:
- Amie Smirthwaite, BEng, PhD - Senior Vice President, Global Intelligence & Innovation
- Nancy Morrison, RAC - Executive Director, Regulatory & Quality Consulting Services
- Jonathan Gimbel, PhD - Executive Director, Technical Leadership, Clinical & Post-Market Practice
- Andreas Tarnaris, M.D. MD (Res) FRCS (NeuroSur) - Medical Director
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Upcoming events:
- Webinar, 16 November - Overcoming Challenges and Streamlining the SSP and SSCP
- RQM+ Live! #44, 2 December - Success Stories of PMCF Surveys: Strategy and Execution
Stay informed:
- Subscribe to our blog
- Follow us on LinkedIn
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About RQM+
RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.
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This is the audio from RQM+ Live! #42, originally recorded 28 October, 2021.
When we say RQM+ IVD Director Carlos Galamba is no stranger to the IVDR, we really mean he is no stranger to the IVDR! Carlos is not only fresh out of BSI, but was one of three technical managers developing their IVDR program. Since BSI covers close to 50% of the world’s top IVD companies, we think the perspective and experience Carlos brings to the table is absolutely invaluable.
This special edition of RQM+ Live! will be all about sharing his perspective and experience with you.
Having been in the unique position of 2 IVDR notified body designations at BSI, Carlos is completely in the know about how notified bodies are interpreting and implementing the regulation, and what IVD companies can sincerely expect from BSI and other notified bodies. We're unabashedly biased, but if you're in the IVD space, we think there are very few experts out there that would make for a better Q&A session around the IVDR than with Carlos.
Carlos will bring his top-asked questions that he's compiled from when he was with the notified body, and we encourage you to bring your own questions for him! He'll answer them live. When it's all said and done, we're conducting this session so we can help answer your questions, so don't be shy! We think you'll find that Carlos isn't.
Click here to read more about Carlos' notified body involvement and extensive background.
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About RQM+
RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.
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This is the audio from RQM+ Live! #41, originally recorded 14 October, 2021.
Your post-market surveillance (PMS) system complying to the EU MDR was put into place in May 2021. How is it going? Now months later, there are an abundance of issues and questions!
This panel discussion provides a unique opportunity to learn from the experiences of seasoned experts as they share PMCF successes and failures they’ve seen across the industry so far. While there have been and will continue to be plenty of implementation challenges, our esteemed panel has worked through comprehensive solutions and is anxious to share.
Discussion will include:
- Best practices for optimizing PMCF as it relates to the EU MDR implementation
- Typical NB findings and variations in interpretation
- Strategies to overcome audit findings and gaps in your evidence
The panel will include:
- Amie Smirthwaite, BEng, PhD - Global Vice President, Intelligence & Innovation
- Nancy J. Morrison, RAC - Executive Director, Regulatory & Quality Consulting Services
- Jonathan Gimbel, PhD - Executive Director, Technical Leadership, Clinical & Post-Market Practice
- Celeste Ann Maksim, PhD - Chief of Staff, Clinical & Post-Market Practice
- Andreas Tarnaris, M.D. MD (Res) FRCS (NeuroSur) - Medical Director
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About RQM+
RQM+ is the leading international provider of regulatory, quality and compliance consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.
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This is the audio-only version of RQM+ Live! #40, originally recorded 30 September, 2021.
This has been a very common question from device manufacturers since FDA issued guidance on “least burdensome” almost 20 years ago. FDA defines “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.
Some manufacturers have strong opinions about pushing back on FDA with the argument of utilizing the least burdensome approach, while others are very hesitant to burn bridges. What’s the best approach to get the results you desire while not becoming FDA’s arch nemesis? Join our regulatory experts including former FDA CDRH representatives for a detailed discussion on the process and best practices for disagreeing with FDA.
The panelists:
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Kevin Go - Project Engineer (former FDA CDRH Lead Reviewer)
- Bryan Pinder - Project Engineer (former FDA CDRH Lead Reviewer)
- Ryan Randall - Senior Engineer (former FDA CDRH Lead Reviewer)
Questions answered:
- How do you push back on FDA when you don't agree?
- Where did the phrase least burdensome come from and what does it actually mean?
- Does FDA hate to hear the words least burdensome?
- Do you actually write the words "least burdensome?"
- What's the difference between the least burdensome flag with the new process and an appeal?
- Should a manufacturer be weary of using the least burdensome flag process, or appealing in general?
- Can a reviewer handle a least burdensome flag on their own? Could they resolve it?
- How do you balance timing? (going through the proper steps before appealing and throwing the flag, but keeping other time restrictions in mind)
- When should you file a formal appeal vs. throw the least burdensome flag?
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About RQM+
RQM+ is the leading international provider of regulatory, quality and compliance consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #39, originally recorded 26 August, 2021.
The climb to MDR certification is well underway for device manufacturers. It's been quite an undertaking, but with careful planning, budgeting and execution, it has and will lead to continued successful commercialization of medical devices and IVD’s in the EU. However, achieving certification is just the beginning. Compared to the MDD and IVDD, it will be quite challenging keeping up with all the new requirements for post-market reporting and documentation updates that these trigger. And although many IVD manufacturers are just getting started on the journey to IVDR certification, given the sheer volume of new requirements, the earlier you to start preparing for the post-market phase the better.
With heftier regulatory files to maintain, highly detailed clinical evaluations and PMCF/PMPF plans, many new PMS reporting requirements, and expectations for much more coordinated review of and updates to regulatory, clinical, and risk documentation at a higher frequency than ever before, it's critical to start considering how all of this will be accomplished in the years ahead. Something like a "simple" design change may never have the word simple in front of it again when considering the impact of any product modification across functions and documentation.
In this show we'll talk about what life will look like for regulatory, clinical, quality and PMS functions as we enter MDR/IVDR sustaining mode, and continue to support getting new products to market. Please bring your questions for our experts… we're here to help!
The panel will include:
- Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services
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About RQM+
RQM+ is the leading international provider of regulatory, quality and compliance consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #38, originally recorded 22 July, 2021.
Market consolidation and acquisitions along with the relocation of design centers and manufacturing facilities to OUS locations are resulting in what appears to be a continuous cycle of site transfers for medical device companies. RQM+ is a strategic partner to these companies, providing all things regulatory and quality associated with the transfers. Our subject matter experts have case studies, lessons learned and best practices across activities in regulatory registrations, quality systems, process validations, project management, and remediation. In this show we'll discuss solutions to some of the biggest gaps and challenges we encounter, including
- Mass quantities of labeling revisions
- Quality Plan to bridge the gaps: quality management systems, site and product registrations, process validation, calibration, equipment maintenance
- Process validation in a different country and unexpected challenges
- Project management that ensures QA/RA activities are appropriately prioritized
- Staffing
- And more!
Join our discussion and bring your questions for our subject matter experts! They'll be ready and excited to answer.
The panel will include:
- Ralph Asencio - Vice President of Technical Services
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Catherine Kang - Senior Engineer
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About RQM+
RQM+ is the world's leading (and largest) medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #37, originally recorded June 17, 2021.
The U.S. FDA provides multiple pathways to expedite regulatory clearance/approval for much needed innovative devices. As a regulatory consultancy, we've had the opportunity to support manufacturers achieve successful entry to the market using these various pathways. We're very excited about FDA's recently released Safer Technologies Program (STeP) Guidance Document which fills in the gaps for devices that target important conditions that are not covered by the Breakthrough Devices Program and provides another mechanism to get safer treatments more quickly to the patients who need them.
We often get the questions, "Where do I start?" and "How do I know if my device qualifies?" In this Live! show, our panel of regulatory experts (including former FDA CDRH representatives) will discuss the following and more:
- Is your device really innovative? Everyone thinks their product is the best thing since sliced bread but will FDA agree?
- Tips and tricks when considering these programs - STeP, Breakthrough, CDRH Innovation/CDRH Payor communication task force
- The STeP Program being new, what should you expect from the Agency initially, and what are the uncertainties around how the STeP will be applied
- Is FDA responding to Q-sub requests from innovators during the pandemic?
- Is clinical data needed before submitting the breakthrough application or is it dependent on the device/OHT?
- Is being “innovative” worth it if it will require additional clinical evidence?
- Where are we seeing ‘Innovative Devices’ emerge and where do we think the industry is headed?
If you'd like to learn more about the options and challenges associated with getting innovative devices to the US market, please join us and bring your tough questions for our panel to answer live!
The panel will include:
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Kevin Go - Project Engineer (former FDA CDRH Lead Reviewer)
- Bryan Pinder - Project Engineer (former FDA CDRH Lead Reviewer)
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About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio recording from our panel discussion at the MassMEDIC Mid-Year FDA Update event held on April 20, 2021. You can watch the panel discussion on our website here. RQM+ is an Associate Member of MassMEDIC and is sponsoring their FDA series this year (look for another event in December). We're always delighted to collaborate with the team at MassMEDIC.
FDA Submissions in 2021: How's it going?
With a focus on FDA regulatory submissions, this panel discussion will provide context for what occurred in 2020 and early 2021, and provide forward-looking guidance and expectations for the remainder of the year. Will the rest of 2021 be smooth sailing or is there turbulence ahead? Our panel of esteemed regulatory experts, including former FDA CDRH representatives and regulatory leaders from multi-national medical device manufacturers, will discuss their thoughts on FDA focus areas, new guidance documents, and requirements on the way, along with the continued impact of COVID-19 on FDA resources and submission timelines. They’ll also react to FDA Director of the Center for Devices and Radiological Health Jeff Shuren’s presentation being held immediately prior.
The panel includes:
- Judith E. O’Grady, RN,MSN,RAC – Corporate Vice President Global Regulatory Affairs, Integra LifeSciences
- Emilia Gonzalez – Global Manager, RA/QA, MIM Software Inc.
- Elijah Wreh – Elijah Industry Representative for FDA Neurological Advisory Committee Device Panel and Regulatory Affairs Manager, Zimmer Biomet
- Nancy Morrison – Executive Director of Regulatory and Quality Consulting Services, RQM+
- Kevin Go – Senior Engineer, RQM+ (Former CDRH Lead Reviewer)
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About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #36, originally recorded June 3, 2021.
We're back for part two! With so many questions we couldn't address during our April 22, 2021 show on this topic (available on demand), we needed to come back a second time. This is clearly a topic many of you are interested in and we want to help, so here's a second chance to learn from RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day.
"Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency to address. This finding comes in many shapes and sizes, as do the possible solutions. In this Live! episode, our panel of experts will discuss the following and more:
- What types of clinical evidence gaps are notified bodies citing?
- What are some solutions to enable keeping your devices on the market?
- What's the best approach to documenting clinical evidence weaknesses in your technical documentation, to improve your odds of notified body acceptance?
- How do you leverage your PMCF plan as a mitigation for clinical data weakness?
- How do you make all of the documentation sing together - CER, PMCF plan, SSCP, Risk file, labeling - providing a cohesive clinical evidence story to the notified body that they can feel good about approving?
Our panel includes Amie Smirthwaite, former Head of BSI Global Clinical, and Jai Kutty, just months out of BSI, along with RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day!
- Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services
- Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
- Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services
- Sally Sennitt, MBBS, FRCA - Medical Director
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About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #35, originally recorded May 20, 2021.
PSUR - Periodic Safety Update Report - is a new report required by the EU MDR and IVDR. Device manufacturers must have their PSURs ready for review in May 2022 for Class IIb and III devices, and May 2023 for Class IIa devices.
It may feel like there is plenty of time to prepare and no need to start yet, but it's important to recognize the amount of work involved in implementing this new process for an entire portfolio. Identifying database limitations, finalizing a process and template, and finding efficiencies will be keys to creating a smooth process. Similarly, Health Canada's new requirements for post-market summary reports and issue-related analyses for Class II, III, and IV medical devices come into force December 2021. Starting implementation of both the PSUR and HC Summary Report requirements now will enable time to establish an effective and efficient process that doesn't drain your resources.
We're supporting clients with implementation and have received many questions. Here are some of the questions that we plan to discuss in this show:
- What is the best approach to implementing the PMS plan?
- What are best practices that improve efficiency?
- How do we deal with the clinical literature being updated if its off-cycle from the CER?
- Is it ok for the PSUR to just reference the literature in the CER?
- How many years of data do we need to include?
- What do we do if our databases don't support implementation of the PMS plan? For example, if we only keep 2 years of sales data.
- What are the best methods of statistical trending for vigilance reporting?
- How do we align Health Canada and MDR requirements and expectations? What are ways to simplify the report to meet both requirements?
Please bring your questions for our SME's and former notified body leaders to answer LIVE!
Panelists:
- Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Service
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Celeste Maksim, Ph.D. RAC - Senior Manager, PMS and PMCF Services
- Brian Hockett - Principal Engineer
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About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #34, originally recorded May 6, 2021.
We all have the same goals when submitting technical documentation to the notified body for review:
- Minimize questions
- Minimize deficiencies
- Achieve certification
There are many strategies to improve your odds, and this panel of experts knows them well. We'll discuss the easy solutions, such as simply using terminology and organizing your file in a way that the notified body reviewers expect. This may sound obvious, but we've all worked at manufactures who wanted their regulatory files to be different than recommended.
We'll also discuss more complicated but necessary strategies, like telling a consistent story of clinical evidence across promotional claims, risk management, clinical evaluation, and post-market surveillance.
Many of us like to use the metaphor that while you may all be wonderful singers individually, if you are each singing from different sheet music... well, it will sound awful to the audience.
This panel of subject matter experts includes our esteemed former notified body leaders as well as our seasoned regulatory professionals who have created many MDD and MDR technical documentation files. No matter how long you've been in the industry, we believe that you'll leave this discussion with some new tips and tricks to take back to your team.
Panelists:
- Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Ruthanne Vendy, RAC - Senior Principal Specialist
- Melissa DeHass - Senior Regulatory Specialist
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About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #33, originally recorded April 22, 2021.
"Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency to address. This finding comes in many shapes and sizes, as do the possible solutions. In this Live! episode, our panel of experts will discuss the following and more:
- What types of clinical evidence gaps are notified bodies citing?
- What are some solutions to enable keeping your devices on the market?
- What's the best approach to documenting clinical evidence weaknesses in your technical documentation, to improve your odds of notified body acceptance?
- How do you leverage your PMCF plan as a mitigation for clinical data weakness?
- How do you make all of the documentation sing together - CER, PMCF plan, SSCP, Risk file, labeling - providing a cohesive clinical evidence story to the notified body that they can feel good about approving?
Our panel include Amie Smirthwaite, former Head of BSI Global Clinical, and Jai Kutty, just weeks out of BSI, along with RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day!
Panelists:
- Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services
- Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
- Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services
- Celeste Maksim, Ph.D. RAC - Senior Manager, PMS and PMCF Services
- Sally Sennitt, MBBS, FRCA - Medical Director
-
About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #32, originally recorded April 8, 2021.
The MDR Date of Application is just around the corner, and there is no indication of another delay coming. If some or all of your products won't be ready in time, you may be starting to panic. In this show we'll start by debunking the bad ideas that we've heard. Here are some examples:
- No, you should not reclassify all of your Class I devices to Class Ir to gain extra time; classifications need to be done correctly
- No, you should not start calling your medical device software not a medical device to avoid compliance
- No, you should not ignore your non-medical accessory software that's part of your system when implementing the MDR. The notified bodies are not letting this pass.
- No, you should not start with a weak PMS plan to enable hitting the target date with an intention to revise before your next surveillance audit.
The above strategies can put your company's CE marking and reputation with the notified body in serious jeopardy. However, there are effective strategies for staying on the market as long as possible while also remaining compliant. Please join our former notified body leaders and regulatory subject matter experts for an informative discussion and bring your questions and ideas!
Panelists:
- Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services
- Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Felicia Hosey, RAC - Senior Principal Specialist
- Brian Hockett - Principal Engineer
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About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #31, originally recorded March 25, 2021.
In connection with biological equivalence, the MDR states, “the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables.”
The intent behind using an equivalence strategy in the EU is to leverage the clinical data from the equivalent device via an assessment of risks arising out of any potential similarities or differences that may have an impact of the established safety/performance profile of the equivalent device.
Simple right? Well actually, no. This has been a big source of confusion for manufacturers in understanding what equivalence really is and having a consistent approach to presenting it in technical documentation.
Join us for an engaging discussion on practical solutions to establishing successful biological equivalence rationales. We'll cover the following and more:
- Are any material differences in biological equivalence acceptable? The MDR says the materials have to be the "same". We'll discuss real life examples.
- The MDR says materials have to be the same. The MDCG guidance expands on what is acceptable. How do we leverage this window effectively?
- How do we leverage EN ISO 10993 test results in support of biological equivalence, beyond mere biological safety evaluation?
- Is the approach for demonstrating biological equivalence different for Class II and Class III devices?
This esteemed panel is comprised of former notified body leaders and regulatory experts in their fourth year of developing and implementing biological equivalence strategies under the MDR.
Panelists:
- Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services
- Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
- Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services
- Celeste Maksim, Ph.D. RAC - Senior Manager, PMS and PMCF Services
- Melissa DeHass - Senior Regulatory Specialist
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About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of RQM+ Live! #30, originally recorded March 11, 2021.
The first and arguably most critical step in the IVDR implementation process is determining if you have a compliant intended purpose statement. This has proven to be challenging, even for legacy devices, and has already resulted in notified body findings for manufacturers who are getting a head start over others in the industry.
It's important the intended purpose statement be compliant while also serving the business strategy. Considerations are:
- Does the statement meet the definition of an IVD device under IVDR?
- Is the statement consistent with the classification of the device under the IVDR?
- Is there sufficient clinical evidence and performance data to support the statement?
- Will gathering additional data cost more than it's worth to market the product?
- Does the statement support what patients need?
- Is the statement narrow enough for regulators to accept it given the clinical evidence?
- Is the statement flexible enough for payers and providers?
In this show our IVDR experts will discuss strategies for developing intended purpose statements, evidence and a compelling story to tie it all together, so that you can continue to market your IVD under the IVDR.
Panelists:
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services
- Celeste Maksim, Ph.D., RAC - Senior Manager, PMS and PMCF Services
- Ron Sills - Senior Principal Specialist
- Paul Briest - Operations Manager / Principal Engineer
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About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #29, originally recorded February 25, 2021.
There has been plenty of discussion regarding what "good enough" means with respect to compliance to the MDR and IVDR. There are many new requirements, and the EU is enforcing much stricter interpretations of requirements that existed under the Directives. A recurring theme is that there will be no “grandfathering” for legacy devices, which means that in some cases significant technical documentation remediation may be required (with similarly significant associated costs). There is also a more explicit emphasis on PMS, PMCF, and continual updates of related documentation. At the same time, the MDR requires much greater transparency of information, as evidenced by requirements such as SSCP, and this will require public disclosure of evidence that manufacturers may previously have considered confidential.
As a result, manufactures may choose to "test the waters" first by submitting technical documentation that pushes the boundaries of what may be perceived to be acceptable. However, does this really save manufacturers money in the long run?
You may be surprised to learn from our former notified body leaders and regulatory experts how much this strategy really costs you. Please join us for this eye-opening discussion!
- Amie Smirthwaite, Ph.D. - Head of Clinical Regulatory Affairs, RQM+
- Jaishankar (Jai) Kutty, Ph.D. - Vice President of Clinical Services, RQM+
- Ron Sills - Senior Principal Specialist, RQM+
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About RQM+ RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #28, originally recorded February 11, 2021.
The MDR and IVDR have significantly increased requirements for clinical, regulatory, and post-market surveillance documentation. To make it even more challenging, there are overlapping requirements resulting in the need for consistent information across a variety of plans and reports. The integration of clinical, regulatory, risk management and post market surveillance is a difficult and confusing task, however, it's essential to ensure consistent information across all plans and reports: CEP/PEP, CER/PER, risk management file, labeling, PSUR, PMCF/PMPF, and SSCP/SSP.
Our experts will discuss how the data inputs and outputs for these documents are interrelated and provide guidance and best practices on how to share information throughout the organization to streamline processes and ensure consistency.
- Amie Smirthwaite, Ph.D. - Head of Clinical Regulatory Affairs, RQM+
- Jaishnankar (Jai) Kutty, Ph.D. - Vice President of Clinical Services, RQM+
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services
- Celeste Maksim, Ph.D. RAC - Senior Manager, PMS and PMCF Services
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About RQM+ RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #27, originally recorded January 28, 2021.
We’re almost one month into 2021... and we're sure everyone's hoping for a much better year than the last! With a focus on FDA regulatory submissions, we would like to provide context for what occurred in 2020 and provide forward-looking guidance for expectations in 2021.
Will 2021 be smooth sailing or is turbulence ahead? Our panel of esteemed regulatory experts, including former FDA CDRH representatives, will discuss their thoughts on FDA focus areas, new guidance documents, and requirements on the way, along with the continued impact of COVID-19 on FDA resources and submission timelines.
Panelists:
- Nancy Morrison - Executive Director, Regulatory and Quality Consulting Services
- Kevin Go - Senior Engineer (former FDA CDRH Lead Reviewer)
- Bryan Pinder - Project Engineer (former FDA CDRH Lead Reviewer)
- Jessica Czamanski - Project Engineer
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About RQM+RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #26, originally recorded January 14, 2021.
In this unique episode of DEVICE L❤️VE Live!, the focus turns to Dr. Amie Smirthwaite, Head of Clinical Regulatory Affairs at RQM+, as she answers questions from our recent EU MDR and IVDR email survey. Amie will be covering a multitude of areas, including legacy products, CERs, PMCF, PSURs, and notified body/commission commentary.
Want to learn more about Amie? Her lengthy credentials are listed below! Please join us this Thursday at 11am ET by registering below, and hear her answers... and have a chance to ask a question of your own.
Credentials:
- Former Global Head of Clinical compliance for BSI Notified Body. Built clinical compliance team and lead clinical aspects of successful MDR designation; also significant contributor to successful IVDR designation on performance evaluation requirements
- A recent contributor to European Commission Clinical Investigations and Evaluations Expert Group, include subgroups which authored the following guidance documents:
- MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies
MDCG 2020-5 Guidance on clinical evaluation – Equivalence
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
MDCG 2020-7 Guidance on PMCF plan template
MDCG 2020-8 Guidance on PMCF evaluation report template
MDCG 2020-13 Clinical evaluation assessment report template
MDCG 2020-x (not yet published) Guidance on PSUR * Contributor to an expert panel on how to assess novelty in medical devices, and SCHEER consultation on phthalates in medical devices * Member of ISO technical committees 194 (Biological and clinical evaluation of medical devices) and 150 (Implants for surgery), a contributor to ISO 14155 and new proposals for clinical evaluation standards
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This is the audio-only version of DEVICE LOVE Live! #25, originally recorded 17 December 2020.
ISO 14971:2019 is not yet harmonized to the EU MDR/IVDR, however, BSI has declared that it is the state of the art and is issuing findings against it in MDR audits. Regardless, it is anticipated the 2019 revision will be harmonized to the regulations and therefore, we recommend manufacturers begin the transition.
In this DEVICE L❤️VE Live! show, our expert panelists will discuss the following and more:
- What are the changes in the 2019 edition?
- What areas can you expect the notified bodies to focus on in audits?
- What are the topics of confusion or debate in the 2019 edition?
Please bring your questions to be answered real time by our experts, including former notified body representatives.
- Ed Ball – Senior Associate, Maetrics
- Nancy Morrison – Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Ron Sills – Senior Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)
- Michael Wolford – Senior Principal Specialist, R&Q
- Nicky Kranz, MHA – Senior Principal Specialist, Consulting Services
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This is the audio-only version of DEVICE LOVE Live! #24, originally recorded 3 December 2020.
The IVDR has detailed requirements for performance evaluation. The new performance evaluation report comprises three separate requirements: scientific validity, analytical validity and clinical evaluation.
The majority of in-vitro diagnostic devices were self-certified in the EU prior to the IVDR. Their legacy status means that the associated technical documentation typically has significant gaps in terms of IVDR requirements, including those upon which scientific validity or analytical performance were based. This means that performance evaluation will be is a formidable task for many manufacturers. To obtain certification under the IVDR, IVD manufacturers must demonstrate performance based on the intended purpose/use, intended user, and other conditions of use such as intended patient population, environment and conditions of sample preparation. Many companies are struggling with the first step of clearly defining the intended purpose, let alone meeting the full gamut of requirements for demonstration of scientific validity, analytical performance and clinical performance.
In this DEVICE L❤️VE Live! session, our panel of experts will discuss what performance evaluation, scientific validity, analytical performance and clinical performance are for IVDs, the steps to generating data that will be accepted by the notified bodies, and our lessons learned so far.
- Amie Smirthwaite, Ph.D. – Head of Global Clinical Practice, Maetrics (recent Head of Global Clinical at BSI)
- Celeste Maksim – Principal Consultant, R&Q
- Mary-Ann Preston – Clinical Practice Manager, Maetrics
- Felicia Hosey – Senior Principal Specialist, R&Q
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This is the audio-only version of DEVICE LOVE Live! #23, originally recorded 19 November 2020.
As defined by the FDA, Real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, like electronic health records and product and disease registries. With the additional requirements of the EU MDR, RWD can also be gathered from PMCF studies and surveys, and EUDAMED. Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).
More simply put, RWD are the data sources obtained outside of a traditional clinical trial, which are then analyzed to generate RWE or used to define a study to create RWE. RWE can provide a faster and more efficient method to meet the evidentiary requirements for FDA and EU regulatory submissions, but it is not without its challenges.
Determining what RWD and RWE are and how to apply them for your device can be daunting. In this show, we will simplify these terms and discuss best practices. We'll also answer the questions we often receive including the following:
- Real world data is often messy as much of it comes from uncontrolled use of the device, so how do I filter out the noise to gain supportive information
- How can I leverage all the PMCF data I need to collect for EU to support an expanded indication in the U.S.? Conversely, how can I leverage FDA RWE to meet my PMCF requirements?
- Would you recommend a pre-submission meeting before collecting RWE to support a new indication?
- What happens if I collect RWE and find a problem – either off-label use or unanticipated adverse events?
Bring your toughest RWD/RWE questions for our experts to answer LIVE!
- Amie Smirthwaite, Ph.D. – Head of Global Clinical Practice, Maetrics (recent Head of Global Clinical at BSI)
- Nancy Morrison – Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Jon Gimbel, Ph.D. – Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team, R&Q
- Celeste Maksim – Principal Consultant, R&Q
- Kevin Go – Senior Engineer (former FDA CDRH Lead Reviewer), R&Q
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #22, originally recorded 5 November 2020.
The Summary of Safety and Clinical Performance or "SSCP" is required by EU MDR for Class III and implantable devices. The SSCP must be reviewed every year, for the lifetime of the device, and is a public facing document. The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device.
The MDCG 2019-9 guidance calls for significant detail that device manufacturers would prefer to keep confidential. As a result, creating an SSCP that meets the regulatory requirements and is acceptable to the Marketing and Legal teams is incredibly challenging. Further complications are having an SSCP that's suitable for patient review, providing multiple translations, and updating this long and comprehensive document annually.
R&Q has submitted multiple SSCPs and received notified body feedback. Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies.
- Ibim Tariah, Ph.D. – VP of EU MDR and IVDR Consulting Services, R&Q (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
- Amie Smirthwaite, Ph.D. – Head of Global Clinical Practice, Maetrics (recent Head of Global Clinical at BSI)
- Nancy Morrison – Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Jon Gimbel, Ph.D. – Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
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This is the audio-only version of DEVICE LOVE Live! #21, originally recorded 22 October 2020.
Will collecting the data be successful?
One of the biggest challenges to EU MDR compliance is meeting the requirements of Post-Market Clinical Follow-up. Many device companies are hoping the combination of literature reviews and PMCF surveys will be “enough” because those approaches are much less resource intensive than registry studies and clinical investigations.
In this show our experts will discuss:
- Circumstances when PMCF surveys are an appropriate PMCF activity
- Documenting justification for the survey activity in the PMCF Plan
(especially as compared to other activities) * Survey feedback from notified bodies; common pitfalls and how to avoid them * Best practices to increasing your odds of a successful notified body review of your survey data and report
If you’re anxious to kick off your survey program but have some concerns, please join us and bring your questions!
Here's the panel:
- Ibim Tariah, Ph.D. – VP of EU MDR and IVDR Consulting Services, R&Q (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
- Amie Smirthwaite, Ph.D. – Head of Global Clinical Practice, Maetrics (recent Head of Global Clinical at BSI)
- Torrie DeGennaro – Associate Engineer, R&Q
- Celeste Maksim, Ph.D. – Principal Consultant, R&Q
- Brian Hockett – Project Engineer, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #20, originally recorded 8 October, 2020.
Although the date of Brexit has passed us, the UK continues to modify its stance for manufacturers’ requirements. In this session, we will dive into the new proposals and how they affect you and your medical devices. We will explore the implications of the CA mark (and its comparability to the CE mark), the UK’s position and stated reversal on EU MDR/EU IVDR, and the expected timelines and grace periods for compliance.
This session will contain critical information for any decision-makers doing business in the UK or Europe in the continually turbulent post-Brexit world.
Here's the panel:
- Ibim Tariah, Ph.D. - VP of EU MDR and IVDR Consulting Services (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
- Nancy Morrison – Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Ed Ball - Senior Associate, Maetrics
- Patrick Mahoney – Principal Specialist, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
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This is the audio-only version of DEVICE LOVE Live! #19, originally recorded 24 September, 2020.
There's a lot of uncertainty in the industry around meeting the requirements of Post-Market Clinical Follow Up (PMCF) under the EU MDR and Post-Market Performance Follow Up (PMPF) under the IVDR.
- Will what I have be enough or am I planning for too much?
- How do I get the functions aligned... PMS, Regulatory, Risk, Clinical, Marketing?
It's not easy!
In this show we'll answer popular questions from our clients and as well as live audience questions. So please, bring your challenges to the table: we'll be ready!
Here's the panel:
- Jon Gimbel, Ph.D. – Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team
- Ron Sills – Senior Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)
- Celeste Maksim, Ph.D. – Principal Consultant
- Niki Caporali-Spaniel, RAC – Principal Specialist
- Brian Hockett – Project Engineer
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #17, originally recorded September 10, 2020.
The Periodic Safety Update Report or "PSUR" is required by EU MDR for each Class IIa, IIb, and III device, and IVDR for Class C and D IVD's. It must be updated it at least every two years, for the lifetime of the device. The PSUR provides a comprehensive risk-benefit analysis with periodic updates, pulling data from multiple sources that may not be accustomed to interacting with each other in an efficient way (Risk Management, CER's, PMCF and PMS/Complaints).
The requirements in the regulation are new and seem to overlap with existing reports. We have yet to see any specific guidance or the PSUR template rumored to be in development and if SSCP and PMCF are any indication, it will be extensive. Where does that leave the industry on how far to go with data and analysis in the initial PSUR, what will be good enough to satisfy the notified bodies?
Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies.
Here's the panel:
- Nancy Morrison – Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Jon Gimbel, Ph.D. – Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team
- Celeste Maksim, Ph.D. – Principal Consultant, R&Q
- Brian Hockett – Project Engineer, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #16, originally recorded August 27, 2020.
Performance Evaluation Plans (PEPs) and Reports (PERs) are now required under the IVDR. Most companies have never performed PERs, which are perhaps the most complicated step to achieving IVDR compliance. Join R&Q's knowledgeable IVDR experts in a panel discussion of strategies and best practices for developing PEP's and PERs. We'll kick off the discussion with questions we've received on the following topics:
- Creating processes and templates for PERs and training your team on how to conduct them
- Grouping products within PERs
- Gathering and presenting data for the state of the art and other reports within the PER
- Conducting lit searches
- Determining what is considered sufficient clinical evidence to satisfy the notified body
We encourage you to bring your own questions for our experts to answer in real time. Don't miss this opportunity!
Here's the panel:
- Ibim Tariah, Ph.D. — VP of EU MDR and IVDR Consulting Services (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
- Jon Gimbel, Ph.D. — Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team
- Ron Sills — Senior Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)
- Eila Pattee — Senior Regulatory Scientist
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #15, originally recorded August 13, 2020.
The rules of requests for feedback and pre-submission meetings with FDA are covered under FDA Guidance Document, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program," issued May 7, 2019.
The FDA Q-Submission (formerly known as pre-sub) Process can be intimidating, beginning with the decision as to whether to request a Q-sub at all. It's a great opportunity to align with FDA or pressure-test on critical items like predicate assignment or test plans before getting too far along in development and spend, however many fear that FDA is more critical of data in the Q-sub than they would be seeing it for the first time in a 510(k) submission. This uncertainty combined with the time commitment to have one often makes it difficult for an RA lead to get the product development team on board with a Q-sub strategy.
In this show, talk with our FDA submission experts including recent CDRH staff about when to use the pre-sub process, real and perceived risks associated with the process, tips and tricks to achieving a successful meeting, and case studies of our experiences.
Here's the panel:
- Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Kevin Go — Senior Engineer (former FDA CDRH Lead Reviewer), R&Q
- Bryan Pinder — Project Engineer (former FDA CDRH Lead Reviewer), R&Q
- Carol Vierling — Senior Principal Advisor, Consulting Services, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #14, originally recorded July 30, 2020.
Based on the amount of questions we're receiving around the definition of a Well-Established Technology (WET), evidence suggests there's a lot of confusion and in turn, potential impact to the industry. The MDR didn't provide a definition, however, the MDCG-6 Guidance on sufficient clinical evidence for legacy devices now provides a definition and further details around sufficient clinical evidence for WET and non-WET devices. Even with this guidance, we're still seeing debate between device companies and their notified bodies on what is classified as WET.
In this show, we'll provide our current thinking on this debate and some tips for interacting with your notified body.
Here's the panel:
- Ibim Tariah, Ph.D. — VP of EU MDR and IVDR Consulting Services (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
- Nancy Morrison, RAC — Executive Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Jon Gimbel, Ph.D. — Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team
- Ron Sills — Senior Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #13, originally recorded July 16, 2020.
It can be difficult to keep software clear of being classified as a medical device when used in healthcare. For example, wellness apps are frequently on the fence, and with every added feature you need to reassess the intended use to ensure you haven't crossed the line into medical device territory.
When a software application is used in conjunction with a medical device, it's even more challenging to keep the app clear of being a medical device itself. Regulatory professionals feel the pressure of software developers and marketers who want the speed to market that's needed to win in this competitive environment.
Most of us in regulatory affairs have been asked by our product development teams questions like,
- "This new app isn't a device, right?"
- "Even though the app talks to a device, how can we keep the app from being a device?"
- "Does the app really need to comply with design controls? It's not really a device, is it?"
In this show we'll discuss:
- Elements of software and intended use that trigger medical device requirements
- Process for making a determination, tips on steering clear of a device classification, and examples on both sides
Here's the panel:
- Nancy Morrison, RAC — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Carol Vierling, RAC — Senior Principal Advisor, Consulting Services, R&Q
- Jessica Andreshak — Senior Principal Specialist, R&Q
- Chad Quistad — Principal Engineer, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #12, originally recorded July 2nd, 2020.
Whether you're on your first 510(k) submission at a startup or your 50th at a large company, you likely have some anxiety over the unpredictability of the process. Let our submission experts will help ease your mind! The panel includes recent CDRH staff who will discuss their tips and tricks for a smooth 510(k) submission process.
We'll cover best practices in all aspects of 510(k) submissions:
- Content
- Compilation
- Format
- Internal review
- Communication with FDA
- Refuse-To-Accept (RTA) issues
- Fulfilling requests for additional information
Here's the panel:
- Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Kevin Go — Senior Engineer (former FDA CDRH Lead Reviewer)
- Bryan Pinder — Project Engineer (former FDA CDRH Lead Reviewer)
- Michael Wolford —Senior Principal Specialist, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #11, originally recorded June 25th, 2020.
Demonstrating "sufficient clinical evidence" is now a clear and enforced requirement for applications under the EU MDR. Additionally, MDR has more explicit requirements to claim equivalency, making it challenging for manufacturers to leverage clinical data generated by other manufactures for similar devices. If you don't have adequate clinical data, what are your options to achieve MDR compliance, especially if you are no longer able to claim equivalency?
In this DEVICE L❤️VE Live! session, our panel will discuss the following and more:
- Best practices and novel approaches to fulfilling sufficient clinical evidence requirements, supported by those that have been accepted by notified bodies in audits
- Since it is also a requirement to disclose risks of the device, we’ll discuss ideas for predicting occurrence rates when disclosing risks when no clinical data is available — specifically, for new products that do not require clinical trials
- Creative ideas for generating data during the COVID-19 pandemic, especially when faced with expectations of receiving minimal feedback or having low study enrollment
- Leveraging CERs to meet the “sufficient clinical evidence” requirements
This panel is loaded with former notified body representatives and seasoned R&Q subject matter experts:
- Ibim Tariah, PhD, R&Q VP of EU MDR/IVDR Consulting Services (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
- Ron Sills, R&Q Sr. Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)
- Jon Gimbel, PhD, R&Q Exec. Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team
- Celeste Maksim, PhD, R&Q Principal Specialist, and post-market surveillance subject matter expert
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #10, originally recorded June 18th, 2020.
The clock is ticking down to the IVDR date of application! May 26, 2022 sounds far away, but it's really not considering the size of the step to IVDR compliance for most IVD companies. The transition from MDD to MDR for medical device manufacturers feels relatively small in comparison to the 85% of IVD companies moving from self-certified to notified body audits, complex regulatory systems, and the expectations of much tighter controls over the web of virtual manufacturing and distribution relationships IVD companies are accustomed to.
This panel will discuss the following and more:
- How far along should IVD companies should be in the transition process?
- What are good milestones to set for 2020 and 2021?
- With limited resources, where should you focus?
- Where do you start with economic operators?
- What does compliance or "good" look like and how do you align on that with your notified body... when at this point, only a few notified bodies are designated?
The panel is stacked with former notified body representatives and experienced R&Q subject matter experts:
- Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Ibim Tariah, Ph.D. — VP of EU MDR/IVDR Consulting Services, R&Q (former BSI)
- Ron Sills — Principal Specialist, R&Q (former TUV Rheinland)
- Justin DiValentino — Principal Specialist, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #9, originally recorded June 11th, 2020.
The FDA 3rd Party Review program has been in use for many years, having been written into law in 1997. On March 12, 2020, FDA released the guidance document, "510(k) Third Party Review Program," based on the draft issued in 2018.
Under the this program, referred to as "3P510k" by FDA, 3P510k Review Organizations review a 510(k) submission and then forward their review, the 510(k) submission, and a recommendation (e.g., substantially equivalent (SE) or not substantially equivalent (NSE)) to FDA. FDA reviews the 3P510k Review Organization’s memo and recommendation and makes a final decision on the submission.
In this Live! session we'll discuss:
- Our experiences with the 3P510k program
- The pros and cons
- Recommendations on when to use it and when to avoid it
If you're contemplating using the program and are trying to assess the risks… great timing!
The panel will include:
- Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Counsel, R&Q
- Ruthanne Vendy — Senior Principal Specialist, R&Q
- Jessica Czamanski — Project Engineer, R&Q
- Katie Dorff — Senior Specialist, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #8, originally recorded June 4th, 2020.
With the EU being on the hot seat lately, and all eyes and discussions on the MDR, you might be left wondering...
— What's the latest in FDA trends?
— Is FDA going harder or lighter on inspections?
— Are 510(k) submissions being scrutinized more than ever – in line with the pendulum swing of the European Commission – or is it status quo for the FDA?
R&Q experts will share what we're seeing across a multitude of device companies with varying clinical specialties and geographies. Attendees should expect to get a glimpse of what to expect! We're looking forward to this one and hope you'll join us.
The panel will include:
- Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Counsel, R&Q
- Jake O'Donnell — Senior FDA Compliance Principal, R&Q (former FDA)
- Kevin Go — Senior Engineer (former FDA)
- Jessica Andreshak, CQA, RAC GS — Senior Principal Specialist, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #7, originally recorded May 28th, 2020.
Under EU MDR, notified bodies are required to look at every technical documentation file at least once in a five-year period. This is alarming for companies with devices marketed 10+ years ago, for which the tech files haven't been reviewed critically since the early years on the market. The risk files for these devices may be thin, and far from compliant to the EU MDR. As an added complication, in the intervening years the Risk Management Standard ISO-14971:2019 has also gone thru a revision. This is the current “State-of-Art” standard referenced for the Risk Management section of the MDR. These changes must also be considered when revising legacy Risk Management Files.
What are some efficient approaches to getting these files audit-ready?
What are the expectations of the notified bodies?
We cover these questions and much more in this Live! session.
Panelists:
- Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
- Nancy Morrison — Executive Director of Regulatory and Quality Consulting Services, R&Q
- Steve Keverline - Vice President of Consulting Operations, R&Q
- Tim Connor - Principal Engineer, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
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This is the audio-only version of DEVICE LOVE Live! #6, originally recorded May 21st, 2020.
Join us for an open discussion with former FDA and Notified body representatives.
— What's it like moving from government to industry?— What do they miss about their previous roles? — Why do they prefer being in industry…or do they? — What do they wish both sides knew about the other? — What are key takeaways to successfully navigate the system?
Panelists:
- Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
- Jon Gimbel, Ph.D. — Executive Director of Regulatory and Quality Consulting Services, R&Q
- Celeste Maksim, Ph.D., RAC — Principal Specialist
- Johnna Dominick — Project Controller
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #5, originally recorded May 14th, 2020.
Join us for an open discussion with former FDA and Notified body representatives.
— What's it like moving from government to industry?— What do they miss about their previous roles?
— Why do they prefer being in industry…or do they?
— What do they wish both sides knew about the other?
— What are key takeaways to successfully navigate the system?
Panelists:
- Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
- Ron Sills — Senior Principal Specialist, R&Q (former TÜV Rheinland)
- Kevin Go — Senior Engineer, R&Q (former FDA)
- Bryan Pinder — Project Engineer, R&Q (former FDA)
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #4, originally recorded May 8th, 2020.
Remediation programs at medical device companies are very hard on everyone involved. DHF and manufacturing remediations resulting from government actions (FDA warning letters, EU's non-compliance reports) are the extreme. The proactive efforts needed for many companies to achieve MDD compliance let alone the jump to MDR are no piece of cake either. Remediation often exhausts the team, brings down morale, and leads to much debate over what is "good enough". Let's talk about best practices to enable remediation efforts to be as pain free as possible.
- How do companies keep up morale and avoid turnover during a remediation?
- What are ways to minimize team burnout?
- How do we update the DHF for legacy devices when many of the NPD resources have moved on to other projects or other companies? The documentation is outdated and the tribal knowledge is gone.
- How do you make a decision on "good enough" when patching holes in design history files and tech files?
- Let's talk about proactive remediation versus warning letter remediation…different levels of intensity and project management.
- What are some best practices for DHF remediation efforts?
Panelists:
- Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
- Nancy Morrison, RAC — Executive Director of Regulatory and Quality Consulting Services, R&Q
- Steve Keverline — Vice President of Consulting Operations, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #3, originally recorded May 1st, 2020.
Notified Body auditors have increased scrutiny as promised in both initial Medical Device Regulation (MDR) certification audits and routine Medical Device Directive (MDD) audits. Novel major findings are being issued on long standing processes and legacy products. In this panel discussion, R&Q experts will talk about what we are seeing across the medical device industry. Our experts will provide recommendations on where to focus your resources to increase the odds of passing a notified body audit without major findings.
Panelists:
- Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
- Nancy Morrison, RAC — Executive Director of Regulatory and Quality Consulting Services, R&Q
- Jon Gimbel, Ph.D. — Executive Directory of Regulatory and Quality Consulting Services, R&Q
- Ron Sills — Senior Principal Specialist, R&Q (former TÜV Rheinland)
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #2, originally recorded April 24th, 2020.
In response to the COVID-19 global pandemic, health authorities are taking the necessary steps to allow for greater access to and use of critical medical devices and PPE that are in short supply. However,some manufactures lack the necessary regulatory approvals needed to make their medical devices/PPE available. In situations such as these, both the United States (FDA) and European Union (European Commission) have legislation in place to help bring these critical products to patients and healthcare workers for emergency applications.
In the United States, the US FDA has invoked the Emergency Use Authorization (EUA) authorizing the use of an unapproved product or an unapproved use of an approved product, provided that other statutory criteria are met.
In the European Union, Article 59 of the EU MDR (2017/745) can be used where the European Commission is responsible for identifying and authorizing certain medical devices and PPE that may be sold without CE Marking during the public health emergency and market access is granted individually by the Competent Authority of each member state. The EU has already issued an implementing act restricting export of PPE from the EU and recommended conformity assessment procedures within the context of COVID-19 threat, including extraordinary measures related to notified body audits.
In this show, we’ll discuss both emergency applications and talk with experts on:
- The overall process and requirements
- What products this regulatory route can be used for
- Explain the “shortcuts” this provides
- What these processes are NOT intended for
- And more!
Does your organization have a product that could utilize these pathways? Do you have questions on how to get this done quickly and effectively?
Panelists:
- Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
- Nancy Morrison, RAC — Executive Director of Regulatory and Quality Consulting Services, R&Q
- Niki Spaniel — Senior Principal Specialist, R&Q
- Kevin Go — Senior Engineer, R&Q (former FDA)
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message
This is the audio-only version of DEVICE LOVE Live! #1, originally recorded April 17th, 2020.
The medical device industry’s reliance on China for suppliers, manufacturing sites, and finished medical devices is widespread and well understood. In 2019, the U.S. President leveraged the “International Emergency Economic Powers Act (IEEPA)” in an effort to urge United States companies to begin searching for production alternatives outside of China. The act authorizes the President to regulate foreign economic transactions when a national emergency is declared to manage any unusual and extraordinary foreign source threat to the U.S.
Fast forward to 2020 and we now know that COVID-19 is magnifying the vulnerability of the U.S. and other countries using China for the production of medical devices. Few could predict that we would be faced with the current struggle to obtain a device as simple, yet critical, as a face mask.
Device manufactures have a good handle on how to relocate manufacturing into China; we’ve all been on at least one of those projects in our careers. But how do we move it back out? What are the obstacles and strategies for success?
In this show, we’ll discuss all of the hurdles you may encounter and talk with experts about strategies to overcome them.
Panelists:
- Nancy Morrison, RAC — Executive Director of Regulatory and Quality Consulting Services, R&Q
- Dean Miller — Senior Principal Engineer, R&Q
- Jyothsna Nunna — Principal Engineer, R&Q
- Patrick Mahoney — Principal Specialist, R&Q
Moderator:
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
The and means more.
Send in a voice message: https://anchor.fm/deviceadvice/message