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Medical Device Quality Systems Manual:

A Small Entity Compliance Guide

First Edition (Supersedes the Medical Device Good Manufacturing Practices [GMP] Manual)

  

 

(This page last updated: April 14, 1999)

This page provides information and access to this CDRH manual in its entirety or as individual chapters as shown below:
 
  

    Cover page, Preface, Foreword [Text Format]
    Table of Contents [Text Format]

  1. The Quality System Regulation [Text Format]
  2. Quality Systems [Text Format]
  3. Design Controls [Text Format]
  4. Process Validation [Text Format]
  5. Personnel [Text Format]
  6. Buildings and Environment [Text Format]
  7. Equipment and Calibration [Text Format]
  8. Device Master Record [Text Format]
  9. Document and Change Control [Text Format]
  10. Purchasing and Acceptance Activities [Text Format]
  11. Labeling [Text Format]
  12. Product Evaluation [Text Format]
  13. Packaging [Text Format]
  14. Storage, Distribution, and Installation [Text Format]
  15. Complaints [Text Format]
  16. Servicing [Text Format]
  17. Quality Systems Audits [Text Format]
  18. Factory Inspections [Text Format]
  19. Appendix (Index of appendices)
    1. Appendix 1: The Quality Systems regulation; [Text Format]
    2. Appendix 2: Application of the Medical Device GMPs to Computerized Devices and Manufacturing Processes; [Text Format]

 

 

 

 

 

U.S. Food and Drug AdministrationCenter for Devices and Radiological Health