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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 provides information and access to this CDRH manual in its entirety or as individual chapters as shown below:
Instructions for downloading the PDF reader.
Top of page

  1. The entire manual as originally created in Word Perfect 6.1 has been archived using ZIP format into a single file [qsrman.zip size = 1,929 KB].
  2. As individual chapters listed below. The reconstructed file consists of approximately 7 Megabytes.

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], [PDF] [PDF].
    2. Appendix 2: Application of the Medical Device GMPs to Computerized Devices and Manufacturing Processes; [Text Format], [PDF] [PDF].

Information is available on Portable Document Format [PDF].

If you have questions or comments concerning this page, please contact the Division of Small Manufacturers, International and Consumer Assistance at dsmica@cdrh.fda.gov.

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Updated April 14, 1999

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