Medical Device Regulation
eBook - ePub

Medical Device Regulation

FDA-CDRH Manufacturing, Policies and Regulation Handbook

  1. 678 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Medical Device Regulation

FDA-CDRH Manufacturing, Policies and Regulation Handbook

About this book

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

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Yes, you can access Medical Device Regulation by Elijah Wreh in PDF and/or ePUB format, as well as other popular books in Technology & Engineering & Engineering General. We have over one million books available in our catalogue for you to explore.

Table of contents

  1. Cover
  2. Front Matter
  3. Table of Contents
  4. Copyright
  5. Dedication
  6. Biography
  7. Endorsements
  8. Foreword
  9. Acknowledgments
  10. List of Illustrations
  11. List of Tables
  12. Chapter 1 : Overview of medical device regulation
  13. Chapter 2 : How to market a medical device
  14. Chapter 3 : Premarket notification [510(k)]
  15. Chapter 4 : Device modifications requiring new 510(k) submission
  16. Chapter 5 : Premarket approval (PMA)
  17. Chapter 6 : Investigational device exemption
  18. Chapter 7 : In vitro diagnostics
  19. Chapter 8 : Clinical studies for medical device
  20. Chapter 9 : Medical device labeling requirements
  21. Chapter 10 : FDA Medical Devices Advisory Committees
  22. Chapter 11 : Human factors and medical devices
  23. Chapter 12 : Mobile medical applications, software, and wireless coexistence
  24. Chapter 13 : Cybersecurity in medical devices
  25. Chapter 14 : Postmarket surveillance and requirements
  26. Chapter 15 : Compliance and enforcement
  27. Chapter 16 : The quality system regulation
  28. Chapter 17 : Risk management
  29. Chapter 18 : Meeting and collaboration with the FDA
  30. Chapter 19 : Future of the medical device industry
  31. Appendix : FDA guidance documents (medical devices)
  32. Regulatory affairs professionals society (RAPS)
  33. Quality management system manual
  34. Glossary
  35. Index
  36. A