Medical device software verification, validation and compliance /

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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 you a much broader, hig...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Vogel, David A. (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Boston : Artech House, ©2011.
Temas:
Medical instruments and apparatus > Software.
Software engineering.
Computer software > Quality control.
Software Validation
Device Approval > standards
Software > standards
Génie logiciel.
Logiciels > Qualité > Contrôle.
Logiciels > Validation.
MEDICAL > Instruments & Supplies.
Medical instruments and apparatus.
Electronic books.
Software.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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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