Medical Device Quality Assurance and Regulatory Compliance
eBook - ePub

Medical Device Quality Assurance and Regulatory Compliance

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

Medical Device Quality Assurance and Regulatory Compliance

About this book

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

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Yes, you can access Medical Device Quality Assurance and Regulatory Compliance by Richard C. Fries in PDF and/or ePUB format, as well as other popular books in Medicine & Biomedical Science. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
1998
eBook ISBN
9781040215883

Table of contents

  1. Cover Page
  2. Halftitle Page
  3. Title Page
  4. Copyright Page
  5. Dedication Page
  6. Preface
  7. Contents
  8. Section 1 Standards and Regulations Background
  9. CHAPTER 1 Quality Assurance and Regulatory Compliance
  10. CHAPTER 2 The FDA
  11. CHAPTER 3 The European Union
  12. CHAPTER 4 The Global Harmonization Task Force
  13. CHAPTER 5 The Special Case for Software
  14. CHAPTER 6 The ISO 9000 Series of Standards
  15. CHAPTER 7 ISO 9000 Requirements
  16. CHAPTER 8 The ISO 14000 Series of Standards
  17. CHAPTER 9 ISO 14000 Requirements/Compliance
  18. Section 3 Quality Devices
  19. CHAPTER 10 EN 46001
  20. CHAPTER 11 EN 46001 Requirements/Compliance
  21. CHAPTER 12 The ISO 13485 Standard
  22. CHAPTER 13 ISO 13485 Requirements
  23. CHAPTER 14 IEC 601-1-4
  24. CHAPTER 15 IEC 601-1-4 Requirements/Compliance
  25. CHAPTER 16 ISO 9000-3
  26. CHAPTER 17 ISO 9000-3 Requirements/Compliance
  27. CHAPTER 18 IEC 601-1
  28. CHAPTER 19 IEC 601-1 Requirements/Compliance
  29. Section 4 Regulation
  30. CHAPTER 20 The Medical Devices Directives
  31. CHAPTER 21 The Medical Devices Directives Requirements and Compliance
  32. CHAPTER 22 Quality System Regulations
  33. CHAPTER 23 Quality System Regulation Requirements and Compliance
  34. CHAPTER 24 FDA Submittals
  35. CHAPTER 25 FDA Submittal Requirements and Compliance
  36. Section 5 Appendices
  37. Appendix 1
  38. Appendix 2 Addresses of Quality System Registrars/Notified Bodies
  39. Appendix 3 Addresses of Regulatory Agencies
  40. Appendix 4 Addresses of FDA Offices
  41. Appnedix 5 Addresses of Consulting/Training Organizations
  42. Appendix 6 Addresses of Testing Organizations
  43. Appendix 7 Glossary