155 Episoder

  1. Should Wellness Products Come with a Warning?

    Udgivet: 11.9.2025

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

    Udgivet: 25.6.2025

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

    Udgivet: 10.6.2025

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

    Udgivet: 30.5.2025

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

    Udgivet: 30.5.2025

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

    Udgivet: 23.1.2025

  7. Development Considerations for OTC Medtech, Part 2

    Udgivet: 23.1.2025

  8. Device Descriptions in Regulatory Submissions

    Udgivet: 7.1.2025

  9. Regulatory Ramifications Due to the Presidential Election

    Udgivet: 26.11.2024

  10. Regulatory Considerations with an Assisted Suicide Machine

    Udgivet: 20.11.2024

  11. Predetermined Change Control Plans, Part 2

    Udgivet: 24.9.2024

  12. Predetermined Change Control Plans, Part 1

    Udgivet: 24.9.2024

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

    Udgivet: 3.9.2024

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

    Udgivet: 22.8.2024

  15. Revisiting Real-World Evidence

    Udgivet: 18.6.2024

  16. The Most Dangerous Devices to Hit the Market

    Udgivet: 11.6.2024

  17. Headline-Generating Medical Device Safety Concerns

    Udgivet: 2.5.2024

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

    Udgivet: 19.3.2024

  19. Examining Institutional Review Boards

    Udgivet: 6.3.2024

  20. Reimbursing Breakthrough Designation Products

    Udgivet: 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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