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Medical Device Software Verification, Validation, and Compliance. Text with DVD

Vogel, David A.
Medical Device Software Verification, Validation, and Compliance. Text with DVD Cover Image
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List Price:$139.00


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Book Information
Edition: 1st
Publisher: Artech House, Inc
ISBN: 1-59693-422-0 (1596934220)
ISBN-13: 978-1-59693-422-1 (9781596934221)
Binding: Book with Ancillary Hardcover + DVD
Copyright: 2011
Publish Date: 12/10
Weight: 2.12 Lbs.
Pages: 424
Subject Class: C-S (Computer Science)
Return Policy: Returns accepted up to 18 months provided no other recalls or return restrictions apply. This product contains software or Internet access code(s). Returns are not accepted if seal is broken or if access code revealed.
 
Class Specifications
Abstract: 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. ... 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. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer s quality system and is regulated by 21 CFR 820.70(i). DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book.
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