Description - Six Sigma for Medical Device Design by Jose Justiniano
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.
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