8 FEB 2024 · 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.

13 JAN 2024 · 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.

1 DEC 2023 · 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!

3 NOV 2023 · 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

29 SEP 2023 · 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!

15 MAR 2023 · 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.

25 JAN 2023 · 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.

22 DEC 2022 · 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.

22 NOV 2022 · 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.

4 OCT 2022 · 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.