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Guidelines for Failure Modes and Effects Analysis for Medical Devices

Om Guidelines for Failure Modes and Effects Analysis for Medical Devices

Presents guidelines that focus on failure modes and effects analysis (FMEA) and its application throughout the life cycle of a medical device. This book outlines the major US and EU standards and regulations. It presents an overview of risk management and risk analysis methodologies, and common FMEA pitfalls.

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  • Språk:
  • Engelska
  • ISBN:
  • 9780849319105
  • Format:
  • Häftad
  • Sidor:
  • 190
  • Utgiven:
  • 3. mars 2003
  • Mått:
  • 222x286x14 mm.
  • Vikt:
  • 512 g.
  Fri leverans
Leveranstid: 2-4 veckor
Förväntad leverans: 14. oktober 2025

Beskrivning av Guidelines for Failure Modes and Effects Analysis for Medical Devices

Presents guidelines that focus on failure modes and effects analysis (FMEA) and its application throughout the life cycle of a medical device. This book outlines the major US and EU standards and regulations. It presents an overview of risk management and risk analysis methodologies, and common FMEA pitfalls.

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