
Medical Device Regulation
Description
Key Features
- Unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification
- Puts regulations in the context of contemporary design
- Includes case studies and applications of regulations
Readership
Table of Contents
1. Overview of Medical Device Regulation
2. How to Market a Medical Device
3. Premarket Notification 510(k)
4. Device Modifications Requiring new 510(k) Submission
5. Premarket Approval (PMA)
6. Investigational Device Exemption (IDE)
7. Humanitarian Device Exemption
8. In Vitro Diagnostics
9. Clinical Trials for Medical Devices
10. Medical Device Labeling
11. Overview of Medical Device Classification and Reclassification
12. FDA Advisory Committees
13. Human Factors and Medical Devices
14. Mobile Medical Applications
15. Cybersecurity and Wireless Coexistence
16. Postmarket Requirements (Devices)
17. Compliance & Enforcement
18. Quality System Regulation (QRS)
19. Meeting and Collaboration with FDA
20. Future of Medical Device Regulation
Medical Device Single Audit Program (MDSAP)
Product details
- No. of pages: 350
- Language: English
- Copyright: © Academic Press 2023
- Published: January 1, 2023
- Imprint: Academic Press
- Paperback ISBN: 9780323953542