Annotations for Biomedical Quality Auditor Handbook

Book News
This volume provides information on applying quality auditor principles to the biomedical business, and can be used in conjunction with The ASQ Auditing Handbook, where the general principles are covered in greater detail but without specific application. The handbook is essentially a compilation of a body of knowledge that was tapped into by surveys and careful evaluation. Covering in turn US laws and regulations, technical knowledge, and international standards and guidance, it considers such topics as labeling, electronic records and signatures, risk management guidance, laboratory testing, and the European Union medical device directives. Annotation ©2013 Book News, Inc., Portland, OR (