Guidelines for Failure Modes and Effects Analysis for Medical Devices (Paperback)

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 reaching 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.

Guidelines for Failure Modes and Effects Analysis for Medical Devices is written as a practical guide to achieving corporate consistency while dramatically cutting the time required for studies. It will help you prevent patient injuries, costly product recalls, and production department down-time.

Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

General

Imprint:	Crc Press
Country of origin:	United States
Release date:	March 2003
First published:	2003
Authors:	Dyadem Press
Dimensions:	280 x 210 x 14mm (L x W x T)
Format:	Paperback
Pages:	190
ISBN-13:	978-0-8493-1910-5
Categories:	Books > Business & Economics > Industry & industrial studies > Manufacturing industries > Hi-tech manufacturing industries Books > Medicine > General issues > Medical equipment & techniques > General Books > Business & Economics > Business & management > Management & management techniques > Management decision making > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Other manufacturing technologies > Precision instruments manufacture > General
LSN:	0-8493-1910-2
Barcode:	9780849319105

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