155 Episodes

  1. Strengthening the 510k Program

    Published: 19/12/2023

  2. Medical Device Manufacturing Recalls

    Published: 3/10/2023

  3. AI Predetermined Change Control Plan

    Published: 19/09/2023

  4. Can You Use a Recalled Device as a Predicate?

    Published: 20/06/2023

  5. Leading Issues from FDA Inspections (or History Repeating Itself)

    Published: 4/04/2023

  6. To Regulate or Not to Regulate…LDTs, Part 2

    Published: 7/02/2023

  7. To Regulate or Not to Regulate…Lab Developed Tests, Part 1

    Published: 31/01/2023

  8. What Happens When the EUA Period Ends?

    Published: 13/12/2022

  9. What Does 510k Exempt Actually Mean?

    Published: 29/11/2022

  10. How Can Off-Label Use Be Promoted?

    Published: 15/11/2022

  11. FDA's Intended Use Rule’s Relation to Labeling

    Published: 1/11/2022

  12. Gaining an Advantage Through Class II Special Controls

    Published: 25/10/2022

  13. FDA’s Refuse to Accept Policy for 510(k)s

    Published: 18/10/2022

  14. Initiating a Voluntary Medical Device Recall

    Published: 11/10/2022

  15. A Letter to File Deep Dive

    Published: 4/10/2022

  16. Discussion of Neuromodulation Technology with Medtronic's Dave Anderson

    Published: 31/05/2022

  17. Humacyte’s Bioengineered Tissue Platform Technology

    Published: 8/03/2022

  18. Koya Medical Restores Mobility for Compression Therapy Patients

    Published: 1/03/2022

  19. NeuroPace’s Aid in Tracking and Treating Epilepsy

    Published: 22/02/2022

  20. Aidoc Is Improving Patient Outcomes Through AI

    Published: 15/02/2022

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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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