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FDA > CDRH > Good Manufacturing Practice / Quality Systems > Medical Device Quality Systems Manual

Medical Device Quality Systems Manual

Table of Contents

Return to GMP/Quality Systems Page
  1. The Quality System Regulation -- An Introduction
  2. Quality Systems
  3. Design Controls
  4. Process Validation
  5. Personnel
  6. Buildings and Environment
  7. Equipment and Calibration
  8. Device Master Record
  9. Document and Change Control
  10. Purchasing and Acceptance Activities
  11. Labeling
  12. Product Evaluation
  13. Packaging
  14. Storage, Distribution, and Installation
  15. Complaints
  16. Servicing
  17. Quality Systems Audits
  18. Factory Inspections
  19. Appendix (Index of appendices)

  20. Appendix 1 The Quality Systems regulation.
    Appendix 1 is also available as a PDF file.

  21. Appendix 2 Application of the Medical Device GMPs to Computerized Devices and Manufacturing Processes
    Appendix 2 is also available as a PDF file.

Updated January 7, 1997

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