The most important addition to FDA's new quality system regulation, design control is an essential element in the development and production of high-quality medical devices. This best-selling publication gathers together all of the articles in MD&DI's groundbreaking series on design control, and examines how medical device manufacturers can meet FDA requirements for design and development planning, design input, design output, design verification, and design transfer. Also examined is the role of executive management in implementing design control. Essential reading for the entire team of product development professionals, including management personnel, product designers, production professionals, and marketers.