154 Odcinki

  1. 3 Most Common Premarket (Postmarket?) Review Issues FDA Sees

    Opublikowany: 25.06.2025
  2. Why Are One-Third of MAUDE Reports a Problem?

    Opublikowany: 10.06.2025
  3. FDA Guidance on Off-Label Communication, Part 2

    Opublikowany: 30.05.2025
  4. FDA Guidance on Off-Label Communication, Part 1

    Opublikowany: 30.05.2025
  5. Development Considerations for Over-the-Counter Medtech, Part 1

    Opublikowany: 23.01.2025
  6. Development Considerations for OTC Medtech, Part 2

    Opublikowany: 23.01.2025
  7. Device Descriptions in Regulatory Submissions

    Opublikowany: 7.01.2025
  8. Regulatory Ramifications Due to the Presidential Election

    Opublikowany: 26.11.2024
  9. Regulatory Considerations with an Assisted Suicide Machine

    Opublikowany: 20.11.2024
  10. Predetermined Change Control Plans, Part 2

    Opublikowany: 24.09.2024
  11. Predetermined Change Control Plans, Part 1

    Opublikowany: 24.09.2024
  12. What is a CAPA and How Do You Best Use It?

    Opublikowany: 3.09.2024
  13. You Got a 483 from the FDA. Now what?

    Opublikowany: 22.08.2024
  14. Revisiting Real-World Evidence

    Opublikowany: 18.06.2024
  15. The Most Dangerous Devices to Hit the Market

    Opublikowany: 11.06.2024
  16. Headline-Generating Medical Device Safety Concerns

    Opublikowany: 2.05.2024
  17. Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    Opublikowany: 19.03.2024
  18. Examining Institutional Review Boards

    Opublikowany: 6.03.2024
  19. Reimbursing Breakthrough Designation Products

    Opublikowany: 2.01.2024
  20. Strengthening the 510k Program

    Opublikowany: 19.12.2023

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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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