The Qmed Podcast

Feb 08 2024 3
The Qmed Podcast artwork

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.

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S4_E2_PMCF survey with CETAS Healthcare

Feb 08 2024 63 mins  
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.

S04 E01 Biocompatibility with Ted Heise

Jan 13 2024 32 mins  
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.

S03 E05 - Usual Audit Findings During Medical Device Clinical Studies w. Rikke Boege

Nov 30 2023 30 mins  
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

S03 E04 - Clinical Investigations w. Susanne Dr. Gerbl-Rieger

Nov 03 2023 50 mins  
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

S03 E03 - The Benefit-To-Risk Assessment w. David Rutledge

Sep 29 2023 44 mins  
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!

S03 E02 - Digital Health & Reimbursement

Mar 15 2023 30 mins  
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.

S3 E01 - Sufficient Clinical Evidence

Jan 25 2023 43 mins  
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.

S2 E18 – The Risk-Based Approach in Risk Management

Dec 22 2022 26 mins  
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.

S2 E17 – Navigating Through CAPA

Nov 22 2022 18 mins  
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.

S2 E16 - The Clinical Evaluation Pathway

Oct 04 2022 49 mins  
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.