Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of that goal. These guidelines focus on failure modes and effects analysis (FMEA) and its application throughout the lifecycle of a medical device. Guidelines for Failure Modes and Effects Analysis for Medical Devices outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA (Failure Mode, Effects, and Criticality Analysis).

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