Offering a much broader, higher-level picture than other books in this field,this book helps professionals think critically about software validation -- to build confidence in their software’s safety and effectiveness. The book presents validation activities for each phase of the product lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process. From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations.
- ISBN: 978-1-59693-422-1
- Editorial: Artech House
- Encuadernacion: Cartoné
- Páginas: 432
- Fecha Publicación: 01/12/2010
- Nº Volúmenes: 1
- Idioma: Inglés