Medtech Matters

154 Odcinki

1. Medical Device Manufacturing Recalls

   Opublikowany: 3.10.2023
2. AI Predetermined Change Control Plan

   Opublikowany: 19.09.2023
3. Can You Use a Recalled Device as a Predicate?

   Opublikowany: 20.06.2023
4. Leading Issues from FDA Inspections (or History Repeating Itself)

   Opublikowany: 4.04.2023
5. To Regulate or Not to Regulate…LDTs, Part 2

   Opublikowany: 7.02.2023
6. To Regulate or Not to Regulate…Lab Developed Tests, Part 1

   Opublikowany: 31.01.2023
7. What Happens When the EUA Period Ends?

   Opublikowany: 13.12.2022
8. What Does 510k Exempt Actually Mean?

   Opublikowany: 29.11.2022
9. How Can Off-Label Use Be Promoted?

   Opublikowany: 15.11.2022
10. FDA's Intended Use Rule’s Relation to Labeling

    Opublikowany: 1.11.2022
11. Gaining an Advantage Through Class II Special Controls

    Opublikowany: 25.10.2022
12. FDA’s Refuse to Accept Policy for 510(k)s

    Opublikowany: 18.10.2022
13. Initiating a Voluntary Medical Device Recall

    Opublikowany: 11.10.2022
14. A Letter to File Deep Dive

    Opublikowany: 4.10.2022
15. Discussion of Neuromodulation Technology with Medtronic's Dave Anderson

    Opublikowany: 31.05.2022
16. Humacyte’s Bioengineered Tissue Platform Technology

    Opublikowany: 8.03.2022
17. Koya Medical Restores Mobility for Compression Therapy Patients

    Opublikowany: 1.03.2022
18. NeuroPace’s Aid in Tracking and Treating Epilepsy

    Opublikowany: 22.02.2022
19. Aidoc Is Improving Patient Outcomes Through AI

    Opublikowany: 15.02.2022
20. Performing a Gap Analysis on FDA's Regulatory Protocols

    Opublikowany: 8.02.2022