Medical Device Regulation

FDA-CDRH Manufacturing, Policies and Regulation Handbook

Häftad, Engelska, 2023

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

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Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices.

Offers a 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

Produktinformation

Utgivningsdatum2023-02-24
Mått191 x 235 x 38 mm
Vikt1 400 g
FormatHäftad
SpråkEngelska
Antal sidor678
FörlagElsevier Science
ISBN9780323953542

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Elijah Wreh is an accomplished regulatory affairs leader with a proven track record of success in the medical device industry. Comprehensive experience bringing medical devices to market from viability through design, verification, and validation to global regulatory approvals. Highly proficient at streamlining procedures, implementing best practices, and pulling a talented group of professionals together into a high-performing team. He is an adjunct professor at Case Western Reserve University and the University of Akron, a part-time lecturer at Northeastern University – College of Professional Studies, and a guest lecturer at Cleveland State University. Mr. Wreh’s lecture on regulatory aspects of the medical device product commercialization lifecycle from the United States (US); 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)], Premarket approval (PMA), and Investigational Device Exemption (IDE) submission processes. He is also an Industry Representative for the FDA Neurological Devices Advisory Committee Panel and Vice Chairman of the Board of Directors of CommStar Credit Union. He holds a Master of Arts in Christian Ministry from Liberty University, a Master of Science in Regulatory Science from the University of St. Thomas, and a Bachelor of Science in Human Biology from Minnesota State University. A certificate in Healthcare Compliance from Seton Hall Law School and a Risk Analysis certificate from Harvard T.H. Chan School of Public Health.

Section 1: How to Study and Market a Medical Device1. Overview of Medical Device Regulation2. Regulatory Routes to Market a Medical Device3. Premarket Notification 510(k) 4. Device Modifications Requiring new 510(k) Submission5. Premarket Approval (PMA)6. Investigational Device Exemption (IDE)7. In Vitro Diagnostics8. Clinical Studies for Medical Device9. Medical Device Labeling10. FDA Advisory Committees11. Human Factors and Medical Devices12. Mobile Medical Applications13. Software, Cybersecurity and Wireless Coexistence Section 2: Postmarket Activities and FDA Collaboration14. Postmarket Activities and Requirements15. Compliance and Enforcement16. Quality System Regulation (QRS)17. Risk Management18. Meeting and Collaboration with FDA19. Future of Medical Device RegulationAppendixA: FDA Guidance Documents (Medical Devices)B: Regulatory Affairs Certification (Devices) Practice Exam QuestionsC: Quality Management System (QMS) Manual