153 Episodes

  1. Vital Signs Monitoring Via Telehealth Interface

    Published: 10/20/2020
  2. Multiple Function Device Products

    Published: 9/16/2020
  3. Breakthrough Designation Program Update

    Published: 8/28/2020
  4. 50th Episode: A Look Back

    Published: 8/10/2020
  5. Combination Products Update

    Published: 7/8/2020
  6. Binding vs. Nonbinding FDA Feedback

    Published: 6/10/2020
  7. Real World Evidence Revisited

    Published: 5/14/2020
  8. FDA Pre-Sub Best Practices

    Published: 4/24/2020
  9. Scott Whitaker of AdvaMed on Medtech's Response to COVID-19

    Published: 4/17/2020
  10. COVID-19, Part 2

    Published: 4/8/2020
  11. COVID-19, Part 1

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

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

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

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

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

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

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

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

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

    Published: 10/16/2019

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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.