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Six Sigma for Medical Device Design (Hardcover, New)
Loot Price: R10,868
Discovery Miles 108 680
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Six Sigma for Medical Device Design (Hardcover, New)
Expected to ship within 12 - 17 working days
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For designers of medical devices, the FDA and ISO requirements are
extremely stringent. Designers and researchers feel pressure from
management to quickly develop new devices, while they are
simultaneously hampered by strict guidelines. The Six Sigma
philosophy has solved this dichotomous paradigm for organizations
in other fields, and seeks to do the same for the medical devices
field. 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 provides a how-to guide to
implementing such a program while dispelling commonly held myths
regarding deployment and adoption. 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. For
management wishing to launch innovative medical devices as quickly
as possible, this text establishes a way to align all levels of the
organization to produce a high level of development that is both
timely and compliant. It is also an excellent tool for technical
and scientific personnel to understand the realities of business
and markets and to optimize the product realization process.
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