Practical Design Control Implementation for Medical Devices.
Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers m...
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| Format: | eBook |
| Language: | English |
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Boca Raton :
CRC Press,
2003.
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| Online Access: | Connect to the full text of this electronic book |
| Summary: | Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verific. |
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| Physical Description: | 1 online resource (232 pages) |
| ISBN: | 9781135458102 1135458103 9781574911275 1574911279 |