Written by a team of eminently qualified professionals from the medical device industry, The Biomedical Quality Auditor Handbook serves as a reference source for the application of quality auditing principles to the biomedical industry, including coverage specifically pertaining to medical devices. The book focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing, and includes information on related regulations, directives, standards, and guidance. The book covers a wide range of subjects that have specific interpretations unique to the biomedical industry and can be used in conjunction with the The ASQ Auditing Handbook, Third Edition.

Based on the Body of Knowledge established by ASQ's Biomedical Division, this book is a valuable reference for biomedical professionals who want to execute better audits for medical devices and gain basic knowledge of biomedical technical areas and regulatory requirements.