Six Sigma for Medical Device Design

Jose Justiniano (Mason, Ohio, USA), Venky Gopalaswamy

$735

Hardback

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English

CRC Press Inc
15 November 2004

Regulation of medicines & medical devices; Mathematics & Sciences; Materials science

Filling 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.

By: Jose Justiniano (Mason Ohio USA), Venky Gopalaswamy
Imprint: CRC Press Inc
Country of Publication: United States
Dimensions: Height: 234mm, Width: 156mm, Spine: 13mm
Weight: 358g
ISBN: 9780849321054
ISBN 10: 0849321050
Pages: 148
Publication Date: 15 November 2004
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Active

Regulation, Business, and Six Sigma. Design Control Roadmap. Six-Sigma Roadmap For Product And Process Development. Design Control and Six-Sigma Roadmap Linkages. Measuring Design For Six Sigma Effectiveness. Leadership's Role in Ensuring Success. Conclusion. Appendices.

Jose Justiniano (Mason, Ohio, USA) (Author) , Venky Gopalaswamy (Author)