155 Episoade

  1. The Special 510k Program

    Publicat: 13.11.2019

  2. Beyond 510(k)/PMA—Safer Technologies Program

    Publicat: 16.10.2019

  3. Benefit-Risk Determinations

    Publicat: 16.09.2019

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

    Publicat: 06.08.2019

  5. Beyond 510(k)/PMA—De Novo 101

    Publicat: 02.07.2019

  6. Mike on Medtech: The NYT Editorial Board Statement

    Publicat: 17.06.2019

  7. The Alternative Summary Reporting Program

    Publicat: 24.05.2019

  8. Do we need a pre-sub for 483s? (Part 2)

    Publicat: 09.05.2019

  9. Do we need a pre-sub for 483s?

    Publicat: 09.05.2019

  10. FDA's Material Evaluation

    Publicat: 02.04.2019

  11. 510k Modernization

    Publicat: 25.01.2019

  12. Personalized Healthcare

    Publicat: 03.01.2019

  13. My Holiday Wish List (Part 2)

    Publicat: 11.12.2018

  14. My Holiday Wish List (Part 1)

    Publicat: 04.12.2018

  15. Regulating the Practice of Medicine

    Publicat: 26.10.2018

  16. The Bleeding Edge, Part 3

    Publicat: 26.09.2018

  17. The Bleeding Edge, Part 2

    Publicat: 07.09.2018

  18. The Bleeding Edge, Part 1

    Publicat: 05.09.2018

  19. Breakthrough Designation Program

    Publicat: 10.08.2018

  20. 15 Tips for Getting New Products Through FDA

    Publicat: 03.07.2018

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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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