Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field. Authored by experienced professionals, it uses real world examples to provide a how-to guide for implementation. This volume also links the philosophy with the FDA's Design Control regulation, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. It is an excellent tool for technical and scientific personnel to understand the realities of business and markets and to optimize the product realization process.