Medtech Matters

143 Episodes

1. What is a CAPA and How Do You Best Use It?

   Published: 9/3/2024
2. You Got a 483 from the FDA. Now what?

   Published: 8/22/2024
3. Revisiting Real-World Evidence

   Published: 6/18/2024
4. The Most Dangerous Devices to Hit the Market

   Published: 6/11/2024
5. Headline-Generating Medical Device Safety Concerns

   Published: 5/2/2024
6. Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

   Published: 3/19/2024
7. Examining Institutional Review Boards

   Published: 3/6/2024
8. Reimbursing Breakthrough Designation Products

   Published: 1/2/2024
9. Strengthening the 510k Program

   Published: 12/19/2023
10. Medical Device Manufacturing Recalls

    Published: 10/3/2023
11. AI Predetermined Change Control Plan

    Published: 9/19/2023
12. Can You Use a Recalled Device as a Predicate?

    Published: 6/20/2023
13. Leading Issues from FDA Inspections (or History Repeating Itself)

    Published: 4/4/2023
14. To Regulate or Not to Regulate…LDTs, Part 2

    Published: 2/7/2023
15. To Regulate or Not to Regulate…Lab Developed Tests, Part 1

    Published: 1/31/2023
16. What Happens When the EUA Period Ends?

    Published: 12/13/2022
17. What Does 510k Exempt Actually Mean?

    Published: 11/29/2022
18. How Can Off-Label Use Be Promoted?

    Published: 11/15/2022
19. FDA's Intended Use Rule’s Relation to Labeling

    Published: 11/1/2022
20. Gaining an Advantage Through Class II Special Controls

    Published: 10/25/2022