155 Episodes

  1. The Special 510k Program

    Published: 13/11/2019

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

    Published: 16/10/2019

  3. Benefit-Risk Determinations

    Published: 16/09/2019

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

    Published: 06/08/2019

  5. Beyond 510(k)/PMA—De Novo 101

    Published: 02/07/2019

  6. Mike on Medtech: The NYT Editorial Board Statement

    Published: 17/06/2019

  7. The Alternative Summary Reporting Program

    Published: 24/05/2019

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

    Published: 09/05/2019

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

    Published: 09/05/2019

  10. FDA's Material Evaluation

    Published: 02/04/2019

  11. 510k Modernization

    Published: 25/01/2019

  12. Personalized Healthcare

    Published: 03/01/2019

  13. My Holiday Wish List (Part 2)

    Published: 11/12/2018

  14. My Holiday Wish List (Part 1)

    Published: 04/12/2018

  15. Regulating the Practice of Medicine

    Published: 26/10/2018

  16. The Bleeding Edge, Part 3

    Published: 26/09/2018

  17. The Bleeding Edge, Part 2

    Published: 07/09/2018

  18. The Bleeding Edge, Part 1

    Published: 05/09/2018

  19. Breakthrough Designation Program

    Published: 10/08/2018

  20. 15 Tips for Getting New Products Through FDA

    Published: 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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