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 ..read 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 ..read more

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 ..read more

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 ..read more

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 ..read more

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 ..read more

In this episode, Helene Quie discusses the topic "Conducting Clinical Studies in Hospitals" with study nurse, Christina Møller ..read more

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 ..read more

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 ..read more

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 ..read more