 |
|
 |
USA |
|
|
Quality Rules in Medical Device Manufacture
Revised American Edition (5-pack)
Publication Date June 2002
Publisher CRC Press
Product Type Book
Pages 80
ISBN Number 1574911376
Product Code CRC066
|
|
|
|
|
Summary
# Provides an overview of the FDA quality and medical device regulations
# Describes the kinds of records, reports, and files required
# Discusses the importance of labeling, packaging, cleanliness, and avoiding contamination
# Includes a summary of 21 CFR Part 820 Quality System Regulations
The new edition of the best-selling Quality Rules series is the perfect introduction to Good Manufacturing Practice (GMP) as they relate to the manufacture of medical devices. Drawing significantly on 21 CFR Part 820, the Quality System Regulation for Medical Devices, Quality Rules in Medical Device Manufacture is the ideal training, retraining, and reinforcement resource for workers recently hired into the medical device industry. This handy, easy-to-read booklet covers all the medical device GMP concepts required by the US FDA, the British MCA, and the European GMPs. In a simple, no-nonsense manner, the author explains the rationale of GMP and the key role played by workers in the production and packaging of pure, safe, and quality medical devices.
|
Content
Quality and Medical Devices
Medical Devices and the Law--The FDA
The Paperwork--Records, Reports, and Files
Labels
Cleanliness and Avoiding Contamination
Packaging
Sterile Medical Deices
Conclusion
Appendix A--Classification of medical Devices
Appendix B--Summary of 21 CFR Part 820, Quality System Regulation
|
|
|
