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Practical Design Control Implementation for Medical Devices.
・ISBN 978-0-367-39538-4 paper GB£ 70.99
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お気に入り
★★★
| 著者・編者 | Justiniano, Jose / Gopalaswamy, Venky, |
|---|---|
| 出版社 | (CRC Press, UK) |
| 出版年月 | 2019 |
| ページ数 | 232 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A00-83424＞ |
解説
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 verification, and reliability and design validation.