FDA > CDRH >
Good Manufacturing Practice / Quality Systems > Medical Device Quality Systems Manual: A Small Entity Compliance Guide
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 in its entirety or as individual chapters as shown below: |
|
Top of page |
- The entire manual as originally created in Word Perfect 6.1 has been
archived using ZIP format into a single file [qsrman.zip size = 1,929 KB].
- As individual chapters listed below. The reconstructed file consists of approximately 7
Megabytes.
Cover page, Preface, Foreword [Text Format]
Table of Contents [Text Format]
- The Quality System Regulation [Text Format]
- Quality Systems [Text Format]
- Design Controls [Text Format]
- Process Validation [Text Format]
- Personnel [Text Format]
- Buildings and Environment [Text Format]
- Equipment and Calibration [Text Format]
- Device Master Record [Text Format]
- Document and Change Control[Text Format]
- Purchasing and Acceptance Activities [Text Format]
- Labeling [Text Format]
- Product Evaluation [Text Format]
- Packaging [Text Format]
- Storage, Distribution, and Installation [Text Format]
- Complaints [Text Format]
- Servicing [Text Format]
- Quality Systems Audits[Text Format]
- Factory Inspections[Text Format]
- Appendix (Index of appendices)
- Appendix 1: The Quality Systems regulation; [Text Format], [PDF]
.
- Appendix 2: Application of the Medical Device GMPs to Computerized Devices and
Manufacturing Processes; [Text Format], [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.
Back to Device Advice
Updated April 14, 1999
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