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Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices
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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.
CRC Press; March 2003
95 pages; ISBN 9780203490112
Read online, or download in secure PDF format or MobiPocket
95 pages; ISBN 9780203490112
Read online, or download in secure PDF format or MobiPocket
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9781135495411
9781135495404
9780849319105
9780203490112
0203490118