Medical Device Software Verification, Validation, and Compliance

Massachusetts-based software engineer Vogel is with a private engineering firm specializing in the development and validation of medical devices that are controlled by software. He previously worked at Becton Dickinson Medical Systems and for Honeywell Information Systems. His is the first book written to help medical device and software engineers, QA and compliance professionals, and corporate business managers understand and implement key verification and validation processes for medical device software. Coverage includes some historical and technical background of software validation; validation of software that is an embedded part of a medical device, or software that is itself a medical device; and software that is used in the design, production, maintenance, and control of quality of medical devices. The accompanying DVD contains a collection of FDA regulations and guidance documents, sample forms and templates, and supplemental figures. Annotation c2011 Book News, Inc., Portland, OR (booknews.com)