155 Episoade

  1. Strengthening the 510k Program

    Publicat: 19.12.2023

  2. Medical Device Manufacturing Recalls

    Publicat: 03.10.2023

  3. AI Predetermined Change Control Plan

    Publicat: 19.09.2023

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

    Publicat: 20.06.2023

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

    Publicat: 04.04.2023

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

    Publicat: 07.02.2023

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

    Publicat: 31.01.2023

  8. What Happens When the EUA Period Ends?

    Publicat: 13.12.2022

  9. What Does 510k Exempt Actually Mean?

    Publicat: 29.11.2022

  10. How Can Off-Label Use Be Promoted?

    Publicat: 15.11.2022

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

    Publicat: 01.11.2022

  12. Gaining an Advantage Through Class II Special Controls

    Publicat: 25.10.2022

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

    Publicat: 18.10.2022

  14. Initiating a Voluntary Medical Device Recall

    Publicat: 11.10.2022

  15. A Letter to File Deep Dive

    Publicat: 04.10.2022

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

    Publicat: 31.05.2022

  17. Humacyte’s Bioengineered Tissue Platform Technology

    Publicat: 08.03.2022

  18. Koya Medical Restores Mobility for Compression Therapy Patients

    Publicat: 01.03.2022

  19. NeuroPace’s Aid in Tracking and Treating Epilepsy

    Publicat: 22.02.2022

  20. Aidoc Is Improving Patient Outcomes Through AI

    Publicat: 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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