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.
Product Identifiers
Publisher
Artech House Publishers
ISBN-13
9781596934221
eBay Product ID (ePID)
178236418
Product Key Features
Subject Area
Bioengineering
Author
David a Vogel
Publication Name
Medical Device Software Verification, Validation, and Compliance
Format
Hardcover
Language
English
Subject
Medicine
Publication Year
2011
Type
Textbook
Number of Pages
443 Pages
Additional Product Features
Title_Author
David a Vogel
Country/Region of Manufacture
United States
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