Research Catalog
Six Sigma for medical device design
- Title
- Six Sigma for medical device design / Jose Justiniano, Venky Gopalaswamy.
- Author
- Justiniano, Jose M.
- Publication
- Boca Raton, FL : CRC Press, [2005], ©2005.
Items in the Library & Off-site
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1 Item
| Status | Format | Access | Call Number | Item Location |
|---|---|---|---|---|
| Text | Request in advance | R856.6 .J876 2005 | Off-site |
Holdings
Details
- Additional Authors
- Gopalaswamy, Venky.
- Description
- 133 pages : illustrations; 24 cm
- Summary
- "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. It is a clear-cut solution for companies and designers of medical devices who are faced with the challenges of meeting FDA and ISO requirements." "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."--BOOK JACKET.
- Subjects
- Bibliography (note)
- Includes bibliographical references and index.
- Contents
- Ch. 1. Regulation, business, and Six Sigma -- Ch. 2. Design control roadmap -- Ch. 3. Six Sigma roadmap for product and process development -- Ch. 4. Design control and Six Sigma roadmap linkages -- Ch. 5. Measuring design for Six Sigma effectiveness -- Ch. 6. Leadership's role in ensuring success -- Ch. 7. Conclusion.
- ISBN
- 0849321050 (alk. paper)
- LCCN
- 2004051971
- OCLC
- ocm55596580
- SCSB-5166245
- Owning Institutions
- Columbia University Libraries