Quality Rules in Medical Device Manufacture

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.