Medical Device Regulation

1st Edition - January 1, 2023

Write a review

Author: Elijah Wreh
Paperback ISBN: 9780323953542

Purchase options

Select country/region

Institutional Subscription

Support Center Returns & Refunds

Free Global Shipping

No minimum order

Description

Medical Device Regulations is a handbook on FDA-CDRH current thinking on regulation of medical devices. This book provides information on how devices are determined to meet criteria for being a medical device, what agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This book helps medical device manufacturers both in and out of the United States with premarket application and meeting FDA complex regulatory requirements.Continuous development of medical devices and the associated regulatory affairs is a complex and ever-changing field; this practical, well-structured reference tool will be useful to many professionals in this area. Includes practice exam questions for regulatory affairs certification. This book offers a large and comprehensive overview of the field, and the author has expertise in regulatory affairs and commercialization of medical devices.

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

Regulatory affairs professionals, medical device manufacturers, biomedical engineers working in the field of medical devices. Graduate Master of Science Students in either Regulatory Affairs or Regulatory Science and Law students specializing in Healthcare and Medical Device

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
Published: January 1, 2023
Imprint: Academic Press
Paperback ISBN: 9780323953542

About the Author

Elijah Wreh

Elijah Wreh is an accomplished regulatory affairs leader with a proven track record of success in the medical device industry. Comprehensive experience with bringing medical devices to market from viability through design and, verification, validation to global regulatory approvals. Highly proficient at streamlining procedures, implementing best practices, and pulling a talented group of professionals together into a highly performing team. He is an Adjunct Professor at Case Western Reserve University, Part-Time Lecturer at Northeastern University – College of Professional Studies and guest lecturer at Cleveland State University and the University of Akron. Mr. Wreh’s lecture on regulatory aspects of the medical device product commercialization lifecycle from United States; international perspectives and provisions of the US Food and Drug Administration’s (FDA’s) risk-based medical device classification scheme, such as the Premarket Notification [(510(k)], Pre-Market approval (PMA), and Investigational Device Exemption (IDE) submission processes. He is also a Board Member of CommStar Credit Union in Elyria, OH.

Affiliations and Expertise

Adjunct Professor, Case Western Reserve University; Part-Time Lecturer, Northeastern University and guest lecturer, Cleveland State University and the University of Akron

Ratings and Reviews