Medical Device Design for Six Sigma 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.

Medical Device Design for Six Sigma includes:

• Integrates concept and design methods such as Pugh Controlled Convergence approach, QFD methodology, parameter optimization techniques like Design of Experiment (DOE), Taguchi Robust Design method, Failure Mode and Effects Analysis (FMEA), Design for X, Multi-Level Hierarchical Design methodology, and Response Surface methodology
• Covers contemporary and emerging design methods, including Axiomatic Design Principles, Theory of Inventive Problem Solving (TRIZ), and Tolerance Design
• Provides a detailed, step-by-step implementation process for each DFSS tool included
• Covers the structural, organizational, and technical deployment of DFSS within the medical device industry
• Includes a DFSS case study describing the development of a new device
• Presents a global prospective of medical device regulations

Contents

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 Devices
16. Medical Device Tolerance Design
17. Medical Device DFSS Verifi cation and Validation
18. DFSS Design Transfer
19. Design Change Control, Design Review, and Design History File
20. Medical Device DFSS Case Study

Index

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