155 Afleveringen

  1. Should Wellness Products Come with a Warning?

    Gepubliceerd: 11-9-2025
  2. 3 Most Common Premarket (Postmarket?) Review Issues FDA Sees

    Gepubliceerd: 25-6-2025
  3. Why Are One-Third of MAUDE Reports a Problem?

    Gepubliceerd: 10-6-2025
  4. FDA Guidance on Off-Label Communication, Part 1

    Gepubliceerd: 30-5-2025
  5. FDA Guidance on Off-Label Communication, Part 2

    Gepubliceerd: 30-5-2025
  6. Development Considerations for Over-the-Counter Medtech, Part 1

    Gepubliceerd: 23-1-2025
  7. Development Considerations for OTC Medtech, Part 2

    Gepubliceerd: 23-1-2025
  8. Device Descriptions in Regulatory Submissions

    Gepubliceerd: 7-1-2025
  9. Regulatory Ramifications Due to the Presidential Election

    Gepubliceerd: 26-11-2024
  10. Regulatory Considerations with an Assisted Suicide Machine

    Gepubliceerd: 20-11-2024
  11. Predetermined Change Control Plans, Part 2

    Gepubliceerd: 24-9-2024
  12. Predetermined Change Control Plans, Part 1

    Gepubliceerd: 24-9-2024
  13. What is a CAPA and How Do You Best Use It?

    Gepubliceerd: 3-9-2024
  14. You Got a 483 from the FDA. Now what?

    Gepubliceerd: 22-8-2024
  15. Revisiting Real-World Evidence

    Gepubliceerd: 18-6-2024
  16. The Most Dangerous Devices to Hit the Market

    Gepubliceerd: 11-6-2024
  17. Headline-Generating Medical Device Safety Concerns

    Gepubliceerd: 2-5-2024
  18. Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    Gepubliceerd: 19-3-2024
  19. Examining Institutional Review Boards

    Gepubliceerd: 6-3-2024
  20. Reimbursing Breakthrough Designation Products

    Gepubliceerd: 2-1-2024

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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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