155 Avsnitt

  1. Should Wellness Products Come with a Warning?

    Publicerades: 2025-09-11

  2. 3 Most Common Premarket (Postmarket?) Review Issues FDA Sees

    Publicerades: 2025-06-25

  3. Why Are One-Third of MAUDE Reports a Problem?

    Publicerades: 2025-06-10

  4. FDA Guidance on Off-Label Communication, Part 1

    Publicerades: 2025-05-30

  5. FDA Guidance on Off-Label Communication, Part 2

    Publicerades: 2025-05-30

  6. Development Considerations for Over-the-Counter Medtech, Part 1

    Publicerades: 2025-01-23

  7. Development Considerations for OTC Medtech, Part 2

    Publicerades: 2025-01-23

  8. Device Descriptions in Regulatory Submissions

    Publicerades: 2025-01-07

  9. Regulatory Ramifications Due to the Presidential Election

    Publicerades: 2024-11-26

  10. Regulatory Considerations with an Assisted Suicide Machine

    Publicerades: 2024-11-20

  11. Predetermined Change Control Plans, Part 2

    Publicerades: 2024-09-24

  12. Predetermined Change Control Plans, Part 1

    Publicerades: 2024-09-24

  13. What is a CAPA and How Do You Best Use It?

    Publicerades: 2024-09-03

  14. You Got a 483 from the FDA. Now what?

    Publicerades: 2024-08-22

  15. Revisiting Real-World Evidence

    Publicerades: 2024-06-18

  16. The Most Dangerous Devices to Hit the Market

    Publicerades: 2024-06-11

  17. Headline-Generating Medical Device Safety Concerns

    Publicerades: 2024-05-02

  18. Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    Publicerades: 2024-03-19

  19. Examining Institutional Review Boards

    Publicerades: 2024-03-06

  20. Reimbursing Breakthrough Designation Products

    Publicerades: 2024-01-02

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A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.

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