Medtech Matters

155 Folgen

1. Strengthening the 510k Program

   Vom: 19.12.2023
2. Medical Device Manufacturing Recalls

   Vom: 3.10.2023
3. AI Predetermined Change Control Plan

   Vom: 19.9.2023
4. Can You Use a Recalled Device as a Predicate?

   Vom: 20.6.2023
5. Leading Issues from FDA Inspections (or History Repeating Itself)

   Vom: 4.4.2023
6. To Regulate or Not to Regulate…LDTs, Part 2

   Vom: 7.2.2023
7. To Regulate or Not to Regulate…Lab Developed Tests, Part 1

   Vom: 31.1.2023
8. What Happens When the EUA Period Ends?

   Vom: 13.12.2022
9. What Does 510k Exempt Actually Mean?

   Vom: 29.11.2022
10. How Can Off-Label Use Be Promoted?

    Vom: 15.11.2022
11. FDA's Intended Use Rule’s Relation to Labeling

    Vom: 1.11.2022
12. Gaining an Advantage Through Class II Special Controls

    Vom: 25.10.2022
13. FDA’s Refuse to Accept Policy for 510(k)s

    Vom: 18.10.2022
14. Initiating a Voluntary Medical Device Recall

    Vom: 11.10.2022
15. A Letter to File Deep Dive

    Vom: 4.10.2022
16. Discussion of Neuromodulation Technology with Medtronic's Dave Anderson

    Vom: 31.5.2022
17. Humacyte’s Bioengineered Tissue Platform Technology

    Vom: 8.3.2022
18. Koya Medical Restores Mobility for Compression Therapy Patients

    Vom: 1.3.2022
19. NeuroPace’s Aid in Tracking and Treating Epilepsy

    Vom: 22.2.2022
20. Aidoc Is Improving Patient Outcomes Through AI

    Vom: 15.2.2022