155 Episodo

  1. Strengthening the 510k Program

    Publicado: 19/12/2023

  2. Medical Device Manufacturing Recalls

    Publicado: 3/10/2023

  3. AI Predetermined Change Control Plan

    Publicado: 19/9/2023

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

    Publicado: 20/6/2023

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

    Publicado: 4/4/2023

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

    Publicado: 7/2/2023

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

    Publicado: 31/1/2023

  8. What Happens When the EUA Period Ends?

    Publicado: 13/12/2022

  9. What Does 510k Exempt Actually Mean?

    Publicado: 29/11/2022

  10. How Can Off-Label Use Be Promoted?

    Publicado: 15/11/2022

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

    Publicado: 1/11/2022

  12. Gaining an Advantage Through Class II Special Controls

    Publicado: 25/10/2022

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

    Publicado: 18/10/2022

  14. Initiating a Voluntary Medical Device Recall

    Publicado: 11/10/2022

  15. A Letter to File Deep Dive

    Publicado: 4/10/2022

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

    Publicado: 31/5/2022

  17. Humacyte’s Bioengineered Tissue Platform Technology

    Publicado: 8/3/2022

  18. Koya Medical Restores Mobility for Compression Therapy Patients

    Publicado: 1/3/2022

  19. NeuroPace’s Aid in Tracking and Treating Epilepsy

    Publicado: 22/2/2022

  20. Aidoc Is Improving Patient Outcomes Through AI

    Publicado: 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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