WorldCat Linked Data Explorer

Turtle N-Triple JSON-LD RDF/XML HTML Contact Us Home

http://worldcat.org/entity/work/id/16618644

Six Sigma for Medical Device Design

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 will also be useful to companies.

Open All Close All

type

about

http://schema.org/about

author

contributor

creator

description

http://schema.org/description

  • "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 will also be useful to companies."@en
  • "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."

genre

http://schema.org/genre

  • "Electronic books"
  • "Electronic books"@en

name

http://schema.org/name

  • "Six Sigma for Medical Device Design"
  • "Six Sigma for Medical Device Design"@en
  • "Six sigma for medical devices design"
  • "Six Sigma for medical device design"@en
  • "Six Sigma for medical device design"
  • "Six sigma for medical device design"

workExample