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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)

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(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:
Instructions for downloading the PDF reader.
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  1. The entire manual as originally created in Word Perfect 6.1 has been "zipped" into a single file [qsrman.zip size = 1,929 KB]. Download both the zipped file and PKUNZIP into the same directory. Go to DOS and switch to the directory, e.g., C:\download>, containing these 2 files and type "PKUNZIP"[space]"qsrman.zip". This will create the 23 separate Word Perfect 6.1 files that make up the Quality Systems Manual.

  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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