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

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

For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA re

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise