155 Avsnitt

  1. Strengthening the 510k Program

    Publicerades: 2023-12-19

  2. Medical Device Manufacturing Recalls

    Publicerades: 2023-10-03

  3. AI Predetermined Change Control Plan

    Publicerades: 2023-09-19

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

    Publicerades: 2023-06-20

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

    Publicerades: 2023-04-04

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

    Publicerades: 2023-02-07

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

    Publicerades: 2023-01-31

  8. What Happens When the EUA Period Ends?

    Publicerades: 2022-12-13

  9. What Does 510k Exempt Actually Mean?

    Publicerades: 2022-11-29

  10. How Can Off-Label Use Be Promoted?

    Publicerades: 2022-11-15

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

    Publicerades: 2022-11-01

  12. Gaining an Advantage Through Class II Special Controls

    Publicerades: 2022-10-25

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

    Publicerades: 2022-10-18

  14. Initiating a Voluntary Medical Device Recall

    Publicerades: 2022-10-11

  15. A Letter to File Deep Dive

    Publicerades: 2022-10-04

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

    Publicerades: 2022-05-31

  17. Humacyte’s Bioengineered Tissue Platform Technology

    Publicerades: 2022-03-08

  18. Koya Medical Restores Mobility for Compression Therapy Patients

    Publicerades: 2022-03-01

  19. NeuroPace’s Aid in Tracking and Treating Epilepsy

    Publicerades: 2022-02-22

  20. Aidoc Is Improving Patient Outcomes Through AI

    Publicerades: 2022-02-15

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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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