155 Afleveringen

  1. Strengthening the 510k Program

    Gepubliceerd: 19-12-2023

  2. Medical Device Manufacturing Recalls

    Gepubliceerd: 3-10-2023

  3. AI Predetermined Change Control Plan

    Gepubliceerd: 19-9-2023

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

    Gepubliceerd: 20-6-2023

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

    Gepubliceerd: 4-4-2023

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

    Gepubliceerd: 7-2-2023

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

    Gepubliceerd: 31-1-2023

  8. What Happens When the EUA Period Ends?

    Gepubliceerd: 13-12-2022

  9. What Does 510k Exempt Actually Mean?

    Gepubliceerd: 29-11-2022

  10. How Can Off-Label Use Be Promoted?

    Gepubliceerd: 15-11-2022

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

    Gepubliceerd: 1-11-2022

  12. Gaining an Advantage Through Class II Special Controls

    Gepubliceerd: 25-10-2022

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

    Gepubliceerd: 18-10-2022

  14. Initiating a Voluntary Medical Device Recall

    Gepubliceerd: 11-10-2022

  15. A Letter to File Deep Dive

    Gepubliceerd: 4-10-2022

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

    Gepubliceerd: 31-5-2022

  17. Humacyte’s Bioengineered Tissue Platform Technology

    Gepubliceerd: 8-3-2022

  18. Koya Medical Restores Mobility for Compression Therapy Patients

    Gepubliceerd: 1-3-2022

  19. NeuroPace’s Aid in Tracking and Treating Epilepsy

    Gepubliceerd: 22-2-2022

  20. Aidoc Is Improving Patient Outcomes Through AI

    Gepubliceerd: 15-2-2022

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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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