Medical Device Software: Verification, Validation, and Compliance
This comprehensive book is designed specifically to help medical device and software engineers, quality assurance and compliance professionals, and managers better understand and implement critical verification and validation processes for device software. The book:
- Helps readers to think critically about software validation
- Presents validation activities for each phase of the development lifecycle
- Demonstrates why these activities are important and add value, how to undertake them, and what outputs are needed to document the validation process
From software embedded in medical devices to software that performs as a medical device itself, this book explains how properly handled validation throughout the development lifecycle can bring devices to completion sooner, at higher quality, in compliance with regulations.
Written by David Vogel and published by Artech House, October 2010. 428 pages. DVD included.
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