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.
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
Justiniano, Jose; Gopalaswamy, Venky
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.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
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Hardcover. Etat : Very Good. 1. It's a well-cared-for item that has seen limited use. The item may show minor signs of wear. All the text is legible, with all pages included. It may have slight markings and/or highlighting. N° de réf. du vendeur 1574911279-11-1
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hardcover. Etat : New. In shrink wrap. Looks like an interesting title! N° de réf. du vendeur Q-1574911279
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