416 Epizód

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

    Közzétéve: 2024. 12. 06.

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

    Közzétéve: 2024. 11. 29.

  3. #392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

    Közzétéve: 2024. 11. 22.

  4. #391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

    Közzétéve: 2024. 11. 14.

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

    Közzétéve: 2024. 11. 07.

  6. #389: Pre-determined Change Control Plans

    Közzétéve: 2024. 10. 31.

  7. #388: Elements of an Effective CAPA Program

    Közzétéve: 2024. 10. 24.

  8. #387: The case for Real World Evidence Studies

    Közzétéve: 2024. 10. 17.

  9. #386: The Danger of In-Home Use Medical Devices, Pt. 2

    Közzétéve: 2024. 10. 10.

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

    Közzétéve: 2024. 10. 04.

  11. #384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

    Közzétéve: 2024. 09. 26.

  12. #383: What Standards Apply to My Device?

    Közzétéve: 2024. 09. 19.

  13. #382: Design of Experiments - How and When to Use DOE

    Közzétéve: 2024. 09. 12.

  14. #381: MedTech Advice from an Accidental Entrepreneur

    Közzétéve: 2024. 09. 05.

  15. #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    Közzétéve: 2024. 08. 30.

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

    Közzétéve: 2024. 08. 15.

  17. #378: Who Owns the Design Controls Process?

    Közzétéve: 2024. 08. 08.

  18. #377: Designing a Medical Device for a Global User

    Közzétéve: 2024. 07. 25.

  19. #376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights

    Közzétéve: 2024. 07. 18.

  20. #375: Direct to Consumer - The Future of Healthcare

    Közzétéve: 2024. 07. 11.

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