Six Sigma for Medical Device Design

Six Sigma for Medical Device Design

by Jose Justiniano, Venky Gopalaswamy, Justiniano Justiniano
     
 

ISBN-10: 0849321050

ISBN-13: 9780849321054

Pub. Date: 11/10/2004

Publisher: Taylor & Francis

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

…  See more details below

Overview

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.

Product Details

ISBN-13:
9780849321054
Publisher:
Taylor & Francis
Publication date:
11/10/2004
Pages:
152
Product dimensions:
6.40(w) x 9.60(h) x 0.54(d)

Table of Contents

Regulation, Business, and Six Sigma
Design Control Roadmap
Six-Sigma Roadmap For Product And Process Development
Design Control and Six-Sigma Roadmap Linkages
Measuring Design For Six Sigma Effectiveness
Leadership's Role in Ensuring Success
Conclusion
Appendices
Glossary and Acronyms
Sample Design Control and Six-Sigma Plan for product and process development
Further Reading

Customer Reviews

Average Review:

Write a Review

and post it to your social network

     

Most Helpful Customer Reviews

See all customer reviews >