153 Episoder

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

    Publisert: 10.6.2025
  2. FDA Guidance on Off-Label Communication, Part 1

    Publisert: 30.5.2025
  3. FDA Guidance on Off-Label Communication, Part 2

    Publisert: 30.5.2025
  4. Development Considerations for Over-the-Counter Medtech, Part 1

    Publisert: 23.1.2025
  5. Development Considerations for OTC Medtech, Part 2

    Publisert: 23.1.2025
  6. Device Descriptions in Regulatory Submissions

    Publisert: 7.1.2025
  7. Regulatory Ramifications Due to the Presidential Election

    Publisert: 26.11.2024
  8. Regulatory Considerations with an Assisted Suicide Machine

    Publisert: 20.11.2024
  9. Predetermined Change Control Plans, Part 2

    Publisert: 24.9.2024
  10. Predetermined Change Control Plans, Part 1

    Publisert: 24.9.2024
  11. What is a CAPA and How Do You Best Use It?

    Publisert: 3.9.2024
  12. You Got a 483 from the FDA. Now what?

    Publisert: 22.8.2024
  13. Revisiting Real-World Evidence

    Publisert: 18.6.2024
  14. The Most Dangerous Devices to Hit the Market

    Publisert: 11.6.2024
  15. Headline-Generating Medical Device Safety Concerns

    Publisert: 2.5.2024
  16. Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    Publisert: 19.3.2024
  17. Examining Institutional Review Boards

    Publisert: 6.3.2024
  18. Reimbursing Breakthrough Designation Products

    Publisert: 2.1.2024
  19. Strengthening the 510k Program

    Publisert: 19.12.2023
  20. Medical Device Manufacturing Recalls

    Publisert: 3.10.2023

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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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