How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and

This book provides essential information regarding the new FDA regulation for medical devices and international quality system requirements (ISO 9001 and ISO/DI

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food an

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, researc