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Medical Devices
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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 as individual chapters as shown below:
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Chapters
- Cover page, Preface, Foreword
- Table of Contents
- 1. The Quality System Regulation
- 2. Quality Systems
- 3. Design Controls
- 4. Process Validation
- 5. Personnel and Training
- 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. Appendices
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