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OverviewFilling a void in the published literature, this is the first book available on applying Six-Sigma concepts to medical device design and development. It provides a meaningful linkage with FDA's Design Control guidelines to companies that have to be compliant with regulations including design control. The text provides clarity on the design, development, validation and control of the manufacturing processes that make devices and should appeal to anyone responsible for developing and implementing product process to comply with FDA's Design Control Regulation. It can also be used by companies that are in the process of implementing a quality system for design control. Full Product DetailsAuthor: Jose Justiniano (Mason, Ohio, USA) , Venky GopalaswamyPublisher: Taylor & Francis Inc Imprint: CRC Press Inc Dimensions: Width: 15.60cm , Height: 1.30cm , Length: 23.40cm Weight: 0.358kg ISBN: 9780849321054ISBN 10: 0849321050 Pages: 148 Publication Date: 15 November 2004 Audience: Professional and scholarly , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: In Print ![]() This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsReviewsAuthor InformationJose Justiniano (Mason, Ohio, USA) (Author) , Venky Gopalaswamy (Author) Tab Content 6Author Website:Countries AvailableAll regions |