Medtech Matters

153 Episoder

1. AI Predetermined Change Control Plan

   Publisert: 19.9.2023
2. Can You Use a Recalled Device as a Predicate?

   Publisert: 20.6.2023
3. Leading Issues from FDA Inspections (or History Repeating Itself)

   Publisert: 4.4.2023
4. To Regulate or Not to Regulate…LDTs, Part 2

   Publisert: 7.2.2023
5. To Regulate or Not to Regulate…Lab Developed Tests, Part 1

   Publisert: 31.1.2023
6. What Happens When the EUA Period Ends?

   Publisert: 13.12.2022
7. What Does 510k Exempt Actually Mean?

   Publisert: 29.11.2022
8. How Can Off-Label Use Be Promoted?

   Publisert: 15.11.2022
9. FDA's Intended Use Rule’s Relation to Labeling

   Publisert: 1.11.2022
10. Gaining an Advantage Through Class II Special Controls

    Publisert: 25.10.2022
11. FDA’s Refuse to Accept Policy for 510(k)s

    Publisert: 18.10.2022
12. Initiating a Voluntary Medical Device Recall

    Publisert: 11.10.2022
13. A Letter to File Deep Dive

    Publisert: 4.10.2022
14. Discussion of Neuromodulation Technology with Medtronic's Dave Anderson

    Publisert: 31.5.2022
15. Humacyte’s Bioengineered Tissue Platform Technology

    Publisert: 8.3.2022
16. Koya Medical Restores Mobility for Compression Therapy Patients

    Publisert: 1.3.2022
17. NeuroPace’s Aid in Tracking and Treating Epilepsy

    Publisert: 22.2.2022
18. Aidoc Is Improving Patient Outcomes Through AI

    Publisert: 15.2.2022
19. Performing a Gap Analysis on FDA's Regulatory Protocols

    Publisert: 8.2.2022
20. Stereotaxis’ Robotic Surgery System for Interventional Procedures

    Publisert: 1.2.2022