29 episodes

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.

The Qmed Podcast Qmed Consulting

    • Health & Fitness
    • 5.0 • 2 Ratings

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.

    S3 E01 - Sufficient Clinical Evidence

    S3 E01 - Sufficient Clinical Evidence

    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.

    • 43 min
    S2 E18 – The Risk-Based Approach in Risk Management

    S2 E18 – The Risk-Based Approach in Risk Management

    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.

    • 26 min
    S2 E17 – Navigating Through CAPA

    S2 E17 – Navigating Through CAPA

    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.

    • 18 min
    S2 E16 - The Clinical Evaluation Pathway

    S2 E16 - The Clinical Evaluation Pathway

    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.

    • 49 min
    S2 E15 - The IVDR Transition

    S2 E15 - The IVDR Transition

    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.

    • 51 min
    S2 E14 - How to: EUDAMED

    S2 E14 - How to: EUDAMED

    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.

    • 17 min

Customer Reviews

5.0 out of 5
2 Ratings

2 Ratings

Harm Otten, PhD ,

Thanks to Medical Device Made Easy and Helene

Super helpful. Tak for flere danske stemmer. In English though!

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