Name: Medical Device Regulation By Elijah Wreh (Adjunct Professor, Case Western Reserve University Part-Time Lecturer, Northeastern University and guest lecturer, Cleveland State University and the University of Akron)
SKU: 9780323953542
Price: 203.86 USD
Availability: InStock

Medical Device Regulation Summary

Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook by Elijah Wreh (Adjunct Professor, Case Western Reserve University Part-Time Lecturer, Northeastern University and guest lecturer, Cleveland State University and the University of Akron)

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.

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

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 Device 1. Overview of Medical Device Regulation 2. Regulatory Routes 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. In Vitro Diagnostics 8. Clinical Studies for Medical Device 9. Medical Device Labeling 10. FDA Advisory Committees 11. Human Factors and Medical Devices 12. Mobile Medical Applications 13. Software, Cybersecurity and Wireless Coexistence Section 2: Postmarket Activities and FDA Collaboration 14. Postmarket Activities and Requirements 15. Compliance and Enforcement 16. Quality System Regulation (QRS) 17. Risk Management 18. Meeting and Collaboration with FDA 19. Future of Medical Device Regulation Appendix A: FDA Guidance Documents (Medical Devices) B: Regulatory Affairs Certification (Devices) Practice Exam Questions C: Quality Management System (QMS) Manual

Additional information

Sku

CIN0323953549G

ISBN 13

9780323953542

ISBN 10

0323953549

Title

Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook by Elijah Wreh (Adjunct Professor, Case Western Reserve University Part-Time Lecturer, Northeastern University and guest lecturer, Cleveland State University and the University of Akron)

Author

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

Condition

Used - Good

Binding type

Paperback

Publisher

Elsevier Science & Technology

Year published

2023-02-24

Number of pages

678

Prizes

N/A

Cover note

Book picture is for illustrative purposes only, actual binding, cover or edition may vary.

Note

This is a used book - there is no escaping the fact it has been read by someone else and it will show signs of wear and previous use. Overall we expect it to be in good condition, but if you are not entirely satisfied please get in touch with us

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

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

Faster Shipping

Medical Device Regulation Summary

Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook by Elijah Wreh (Adjunct Professor, Case Western Reserve University Part-Time Lecturer, Northeastern University and guest lecturer, Cleveland State University and the University of Akron)

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

Table of Contents

Additional information

Customer Reviews - Medical Device Regulation