35 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 • 1 Rating

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.

    S4_E2_PMCF survey with CETAS Healthcare

    S4_E2_PMCF survey with CETAS Healthcare

    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.

    • 1 hr 3 min
    S04 E01 Biocompatibility with Ted Heise

    S04 E01 Biocompatibility with Ted Heise

    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.

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

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

    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!

    • 30 min
    S03 E04 - Clinical Investigations w. Susanne Dr. Gerbl-Rieger

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

    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

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

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

    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!

    • 44 min
    S03 E02 - Digital Health & Reimbursement

    S03 E02 - Digital Health & Reimbursement

    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.

    • 30 min

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