Medtech Matters

143 Episodes

1. COVID-19, Part 1

   Published: 4/1/2020
2. EtO Sterilization Concerns

   Published: 3/30/2020
3. FDA's eSTAR Program

   Published: 3/3/2020
4. Human Factors/Usability, Part 2

   Published: 2/3/2020
5. Human Factors/Usability, Part 1

   Published: 2/3/2020
6. Change Management, Part 2

   Published: 1/20/2020
7. Change Management, Part 1

   Published: 1/20/2020
8. Safety and Performance Based 510k

   Published: 12/5/2019
9. The Special 510k Program

   Published: 11/13/2019
10. Beyond 510(k)/PMA—Safer Technologies Program

    Published: 10/16/2019
11. Benefit-Risk Determinations

    Published: 9/16/2019
12. Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program

    Published: 8/6/2019
13. Beyond 510(k)/PMA—De Novo 101

    Published: 7/2/2019
14. Mike on Medtech: The NYT Editorial Board Statement

    Published: 6/17/2019
15. The Alternative Summary Reporting Program

    Published: 5/24/2019
16. Do we need a pre-sub for 483s? (Part 2)

    Published: 5/9/2019
17. Do we need a pre-sub for 483s?

    Published: 5/9/2019
18. FDA's Material Evaluation

    Published: 4/2/2019
19. 510k Modernization

    Published: 1/25/2019
20. Personalized Healthcare

    Published: 1/3/2019