Table of Contents

MEDICAL DEVICE DESIGN FOR SIX SIGMA; CONTENTS; Foreword; Preface; 1 Medical Device Design Quality; 2 Design for Six Sigma and Medical Device Regulation; 3 Basic Statistics; 4 The Six Sigma Process; 5 Medical Device Design for Six Sigma; 6 Medical Device DFSS Deployment; 7 Medical Device DFSS Project Road Map; 8 Quality Function Deployment; 9 DFSS Axiomatic Design Method; 10 DFSS Innovation for Medical Devices; 11 DFSS Risk Management Process; 12 Medical Device Design for X; 13 DFSS Transfer Function and Scorecards; 14 Fundamentals of Experimental Design. 15 Robust Parameter Design for Medical Devices16 Medical Device Tolerance Design; 17 Medical Device DFSS Verification and Validation; 18 DFSS Design Transfer; 19 Design Change Control, Design Review, and Design History File; 20 Medical Device DFSS Case Study; Glossary: DFSS Terminology; Appendix: Statistical Tables; References; Index. The first comprehensive guide to the integration of Design for Six Sigma principles in the medical devices development cycle. Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness presents the complete body of knowledge for Design for Six Sigma (DFSS), as outlined by American Society for Quality, and details how to integrate appropriate design methodologies up front in the design process. DFSS helps companies shorten lead times, cut development and manufacturing costs, lower total life-cycle cost, and improve the quality of the medical devices. Comprehensive and complete.