416 Episodes

  1. #394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues

    Published: 12/6/2024
  2. #393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

    Published: 11/29/2024
  3. #392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

    Published: 11/22/2024
  4. #391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

    Published: 11/14/2024
  5. #390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

    Published: 11/7/2024
  6. #389: Pre-determined Change Control Plans

    Published: 10/31/2024
  7. #388: Elements of an Effective CAPA Program

    Published: 10/24/2024
  8. #387: The case for Real World Evidence Studies

    Published: 10/17/2024
  9. #386: The Danger of In-Home Use Medical Devices, Pt. 2

    Published: 10/10/2024
  10. #385: The Trouble with Home-Use Devices, Pt. 1

    Published: 10/4/2024
  11. #384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

    Published: 9/26/2024
  12. #383: What Standards Apply to My Device?

    Published: 9/19/2024
  13. #382: Design of Experiments - How and When to Use DOE

    Published: 9/12/2024
  14. #381: MedTech Advice from an Accidental Entrepreneur

    Published: 9/5/2024
  15. #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    Published: 8/30/2024
  16. #379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer

    Published: 8/15/2024
  17. #378: Who Owns the Design Controls Process?

    Published: 8/8/2024
  18. #377: Designing a Medical Device for a Global User

    Published: 7/25/2024
  19. #376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights

    Published: 7/18/2024
  20. #375: Direct to Consumer - The Future of Healthcare

    Published: 7/11/2024

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The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.