Medtech Matters

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