Guidelines for failure modes and effects analysis for medical devices
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. A practical guide to achieving corporate consistency while...
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| Format: | eBook |
| Language: | English |
| Language Notes: | English. |
| Published: |
[Place of publication not identified]
CRC Press,
2018.
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| Series: | FMEA for medical devices
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| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
| Summary: | 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. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses 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 regulat. |
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| Physical Description: | 1 online resource |
| Bibliography: | Includes bibliographical references. |
| ISBN: | 9780429205804 0429205805 1135495416 9781135495411 9786612778797 6612778792 0203490118 9780203490112 |