Guidelines for Failure Modes and Effects Analysis for Medical Devices

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Mukaan Dyadem Press
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190 psl.

2018 m.

Kietas viršelis

Viivakoodi: 9781138464100
Kuvaus

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.