Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices (English Edition)

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 life cycle of a medical device. It 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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