Medtech Matters

155 Episodo

1. Should Wellness Products Come with a Warning?

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

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

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

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

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

   Publicado: 23/1/2025
7. Development Considerations for OTC Medtech, Part 2

   Publicado: 23/1/2025
8. Device Descriptions in Regulatory Submissions

   Publicado: 7/1/2025
9. Regulatory Ramifications Due to the Presidential Election

   Publicado: 26/11/2024
10. Regulatory Considerations with an Assisted Suicide Machine

    Publicado: 20/11/2024
11. Predetermined Change Control Plans, Part 2

    Publicado: 24/9/2024
12. Predetermined Change Control Plans, Part 1

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

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

    Publicado: 22/8/2024
15. Revisiting Real-World Evidence

    Publicado: 18/6/2024
16. The Most Dangerous Devices to Hit the Market

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

    Publicado: 2/5/2024
18. Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    Publicado: 19/3/2024
19. Examining Institutional Review Boards

    Publicado: 6/3/2024
20. Reimbursing Breakthrough Designation Products

    Publicado: 2/1/2024