Design Controls for the Medical Device Industry

This second edition of a bestseller provides a comprehensive review of design control requirements, as well as techniques to ensure your design control program follows current industry practice. The text assists you in developing a program that not only satisfies US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets third-party auditor/investigator expectations. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in practical updates to all chapters and appendices of the book.