Medical Device Software Verification, Validation and Compliance - Hardcover

David A. Vogel

Hardcover

ISBN 10: 1596934220 ISBN 13: 9781596934221

Publisher: Artech House Publishers, 2010

Synopsis

Here's the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. 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, and in compliance with regulations.

Edition details

• Publisher: Artech House Publishers
• Publication date: 2010
• Language: English
• ISBN 10: 1596934220
• ISBN 13: 9781596934221
• Binding: Hardcover
• Number of pages: 432