Medical device software verification, validation and compliance

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Bibliographic Details
Main Author Vogel, David A. (Author)
Format Electronic eBook
LanguageEnglish
Published Boston : Artech House, ©2011.
Subjects
Medical instruments and apparatus > Software.
Software engineering.
Computer software > Quality control.
elektronické knihy
electronic books
Online AccessFull text
ISBN9781596934238
1596934239
9781523117390
1523117397
9781596934221
1596934220
Physical Description1 online resource (xix, 424 pages)

Cover

Table of Contents:
  • Machine generated contents note: pt. I Background
  • ch. 1 Evolution of Medical Device Software Validation and the Need for This Book
  • Evolution of Validation in the Medical Device Industry
  • Building a Language to Discuss Validation
  • Terminology is the Foundation
  • Correct Versus Consistent Terminology
  • Terminology Need Not Be Entertaining
  • Risk Management and Validation of Medical Device Software
  • About This Book
  • Goals of This Book
  • Intended Audience
  • Are You Wasting Time?
  • References
  • ch. 2 Regulatory Background
  • FDA: 1906 Through 1990
  • FDA Today (2009)
  • How the FDA Assures Safety, Efficacy, and Security
  • Quality System Regulations and Design Controls
  • Understanding How Regulation Relates to Getting the Job Done
  • Medical Devices Sold Outside the United States
  • References
  • ch. 3 FDA Software Validation Regulations and Why You Should Validate Software Anyway
  • ^

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