The Qmed Podcast: Recent Episodes
Qmed Consulting
Ready to move into the MDR space?
This podcast is for you, if you’re facing challenges within all stages of getting a product to market. To help you we’ve gathered some of the greatest and most influential minds in the Medical Device industry, to get their insights on how to go from an idea to a market success.
You'll be accompanied by our host, Helene Quie, the founder and CEO of Qmed Consulting.
During this episode we will have CETAS Healthcare share their extensive knowhow and perspective on how to set up PMCF surveys and gather important data fulfilling the MDR requirement.
Ted Heise from the MedInstitute is a true subject matter expert within biocompatibility and biological evaluation. He will share during this interesting conversation his view on how to understand the guidances and regulations in the key markets.
I am thrilled to host Rikke Bøge, an esteemed Clinical Affairs Subject Matter Expert, as our special guest on this episode of the Qmed podcast. Rikke's extensive background as a nurse, study coordinator, and Clinical Research Associate brings a depth of experience that's invaluable. She will be sharing her wealth of knowledge and firsthand experiences during audits in the clinical research landscape.
Tune in as we explore real-life scenarios, insights, and strategies to navigate the intricacies of audits in clinical settings. Don't miss this opportunity to gain valuable insights from Rikke's expertise!
During this episode I speak with the subject matter expert Dr. Susanne Gerbl-Reiger about the implementation of MDR and ISO14155 and typical findings observed during her long time experience form AKRA team and TÜV SÜD
In this third episode of the Qmed Podcast we discuss the process of identifying, analysing and consluding on the Risk Benefit Assessment. I am interviewing David Rudledge who shares his experience and knowledge working within this field for medical devices the last 25 years. Listen and enjoy!
Have you ever wondered how digital health is driving the future of healthcare?
Don't miss our new podcast on "Digital Health And Reimbursement" where Ernesto Nogueira and Helene Quie explore the impact of COVID-19 on digital medical technologies, the different types of digital health, and their applications in healthcare.
In the first episode of season 3 of The Qmed Podcast, Helene Quie is joined by Bassil Akra, Akra Team's CEO to discuss the topic of Sufficient Clinical Evidence.
Tune in and learn what to consider when gathering clinical evidence, where to look for guidance and much more.
In this episode of The Qmed Podcast, Helene Quie is joined by Nadia Ragnvald Caspersen, Qmed Consulting's Quality Manager to discuss The Risk-Based Approach in Risk Management. Tune in and learn why a risk-based approacht is essential for your company, how to identify and address risks within Quality Management.
In this episode of The Qmed Podcast, Helene Quie is joined by Jens Johansen, Qmed Consulting's Manager of Strategic Consulting to discuss the CAPA process. Tune in and learn the advantages of establishing this process, relevant tips on how to conduct it and what the next steps are.
In this episode of The Qmed Podcast, Helene Quie is joined by Søren Underbjerg, Qmed Consulting's Principal Advisor within Clinical Development, Market Access and Reimbursement to discuss the Clinical Evaluation Pathway. Tune in and find out what stages you should go through, pitfalls, and relevant tips and tricks we have gathered from dealing with notified bodies.
In this episode of The Qmed Podcast, Helene Quie is joined by Signe Lundsgaard-Nielsen, Qmed Consulting's Principal Advisor of Clinical Development, Market Access & Reimbursement. Here, we discuss one of this year's hot topics - the IVDR transition. Tune in and find out how your device is classified under the new regulation, what the important timelines are and the main consequences of this change.
This episode of The Qmed Podcast addresses one of the most talked about topics in the medical device industry nowadays - EUDAMED. Learn more about it with Qmed's expert, Mads Oliver Jensen.
In this episode, Helene Quie discusses the topic "Conducting Clinical Studies in Hospitals" with study nurse, Christina Møller.
In this episode, Helene Quie discusses the topic "Submissions in Norway" with Qmed's
Clinical Specialists in Submission Processes. Learn about the country's special requirements, where you can the necessary documentation, and relevant tips and tricks for a successful submission process.
In this episode we discuss submissions in Denmark with Clinical Specialist, Christina Duun Nielsen
In this episode, we are joined by Qmed’s market access expert Søren Underbjerg, to discuss the key elements for developing market access strategies.
Richard joined us on a previous episode back in 2019 where he explained basic fundament behind the EUDAMED database. Since then, a lot has happened with the database and in this episode, Richard will provide an overview and explanation of the recent updates and changes to the platform.
In this episode, we are joined by Kami Faust from Norway Health Tech, to discuss what action all medical device manufacturers should take right now to prepare for the upcoming changes.
In this episode we are joined by Lasse Staal, CEO of Danish 3D-Printing Pioneer, AddiFab, to talk about 3D-printing of medical devices.
In this episode of The Qmed Podcast we're joined by Ernesto Nogueira, to talk about Artificial intelligence in the medical device industry.
The RoHS directive is coming! Had the pleasure of talking to Rasmus Lou-Moeller, head of R&D at Meggitt Denmark, about the RoHS directive and how it will affect the medical device industry. Through our conversation, Rasmus explained the pros and cons of the directive and gave advice to medical device manufacturers who are currently using piezoceramics in their products.
Clinical evaluation and the equivalence pathway! Are you in doubt if it is still possible to use the equivalence pathway under MDR? Are there different requirement for different classes of products? How to show equivalence under MDR. Hear practical examples based on feedback from the Notified Bodies.
Had the absolute pleasure of talking to David Rutledge about something I myself find a very difficult assessment process; Benefit - Risk Assessment.
The Benefit - Risk Assessment is mentioned 28 times during the MDR and os one of the core processes especially in the clinical evidence process.
Through our conversation David made the process very tangible and I would clearly recommend listening to our conversation.
Starting a company within the regulatory field of medical devices contains a long series of restrictions, which at times can seem challenging.
In our 2 Episode of our Qmed Consulting Podcast (Season 2), we get an insight of Victor and Andreas, experience within the Quality Management System.
The two engineers have developed a Class IIa medical device. The device measures the amount of oxygen within a child under labor. It prevents unnecessary C-sections, and any complications of birth there may occur.
The Qmed Podcast gives an understanding of how to navigate in an early start-up phase of EQMS.
One of the most common challenges within start-up companies is how to get off the ground and get appropriately funded.
Questions regarding budgeting, pick of the investor, deciding the worth of one's company, and many more.
We have, therefore, in the first episode, of our new second season, invited Bjørn Broby from @Nerescue to give start-up companies a broader understanding of how to navigate in the funding process. We hope you will enjoy listening in and tap in on Bjørn's vast amount of experience.
In this final episode of our first season, Helene looks back at great interviews we've had and share some of her favourite conversations and takeaways. This is a great episode for those who are new to the podcast, but also for our avid listeners to make sure they haven't miss the important points from our talented guests. Have a great summer - See you in the fall!
Human factors and usability are terms often used interchangeably. Yes, it can be a tricky topic, and one that can create some confusion. Therefore, in this episode, I've invited Heidi Mehrzad from HFUX Research to guide us on the difficult topic. Hope you will enjoy listening in and tap in on Heidi’s vast amount of experience.
In this episode of The Qmed Podcast we'll be joined by Richard Houlihan, to talk about "The EUDAMED database and the basic fundament behind". Being part of the European Commission MDR Eudamed technical management position Richard can provide a unique prospective on Eudamed’s inner workings and design bring a better understanding of the Eudamed technical challenges facing companies.
In this episode we are joined by Charlotte Piester from Sinua Partners and discuss how to use clinical and regulatory requirements as commercial competitive advantages within the MedTech industry, completely aligned with the changes to the MDR and the need for companies to carefully consider their claims, market access and which data to collect when – creating The Evidence Gap Plan.
In this episode of The Qmed Podcast we're joined by Ernesto Nogueira, to talk about key steps for SMEs to know about, regarding commercialisation when starting up the development of their innovative new medical device.
Ernesto has numerous years of experience within this field assessing and applying the value of medical technologies in commercial and market access projects.
He is sharing with us key questions to ask yourself early stage during the development process to ensure that you can successfully launch your idea when ready.
In this episode we're proud to welcome Dr. Bassil Akra. We are discussing the MDR - the new regulation and changes to come seen from the side of the Notified Body and touch on important topics such as Technical Documents, new reports such as SPUR and SSCP and use of clinical evidence from equivalent products for low risk class products.
In this episode we’re joined by Sandra Ferretti from the Obelis Group and Authorised Representative out of Brussels and we are discussing the EUDAMED database and the role of the Authorised Representative under the MDR.
In this episode we're guested by Semih Oktay, President and founder of CardioMed Device Consultants. We touch upon getting an overview of FDA structure and organisation and changes to come by June 2019, Risk classification, FDA approval processes and more.
In the first episode of The Qmed Podcast we’re joined by Hilde Viroux from HCL Technologies, to talk about MDR conversion strategy, including maximum use of ‘grace period’, product prioritization, product rationalization and more.