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 - Medical Device Quality Systems Manual Table of Contents - Medical Device Quality Systems Manual 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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