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Good Manufacturing Practice / Quality Systems > Medical Device Quality Systems Manual
Medical Device Quality Systems Manual
Table of Contents
Return to GMP/Quality Systems Page
- The Quality System Regulation -- An Introduction
- Quality Systems
- Design Controls
- Process Validation
- Personnel
- Buildings and Environment
- Equipment and Calibration
- Device Master Record
- Document and Change Control
- Purchasing and Acceptance Activities
- Labeling
- Product Evaluation
- Packaging
- Storage, Distribution, and Installation
- Complaints
- Servicing
- Quality Systems Audits
- Factory Inspections
- Appendix (Index of appendices)
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Appendix 1 The Quality Systems regulation.
Appendix 1 is also available as a PDF file.
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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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