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.
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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