Medtech Matters

143 Episoder

1. COVID-19, Part 1

   Publisert: 1.4.2020
2. EtO Sterilization Concerns

   Publisert: 30.3.2020
3. FDA's eSTAR Program

   Publisert: 3.3.2020
4. Human Factors/Usability, Part 2

   Publisert: 3.2.2020
5. Human Factors/Usability, Part 1

   Publisert: 3.2.2020
6. Change Management, Part 2

   Publisert: 20.1.2020
7. Change Management, Part 1

   Publisert: 20.1.2020
8. Safety and Performance Based 510k

   Publisert: 5.12.2019
9. The Special 510k Program

   Publisert: 13.11.2019
10. Beyond 510(k)/PMA—Safer Technologies Program

    Publisert: 16.10.2019
11. Benefit-Risk Determinations

    Publisert: 16.9.2019
12. Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program

    Publisert: 6.8.2019
13. Beyond 510(k)/PMA—De Novo 101

    Publisert: 2.7.2019
14. Mike on Medtech: The NYT Editorial Board Statement

    Publisert: 17.6.2019
15. The Alternative Summary Reporting Program

    Publisert: 24.5.2019
16. Do we need a pre-sub for 483s? (Part 2)

    Publisert: 9.5.2019
17. Do we need a pre-sub for 483s?

    Publisert: 9.5.2019
18. FDA's Material Evaluation

    Publisert: 2.4.2019
19. 510k Modernization

    Publisert: 25.1.2019
20. Personalized Healthcare

    Publisert: 3.1.2019