The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle
Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide:
* Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology
* Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design
* Provides a detailed, step-by-step implementation process foreach DFSS tool included
* Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry
* Includes a DFSS case study describing the development of a newdevice
* Presents a global prospective of medical device regulations
Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.
Basem El-Haik
Apparatetechnik u. Biosensoren Bioinstrumentation & Biosensors Biomedical Engineering Biomedizintechnik Business & Management Gesundheits- u. Sozialwesen Health & Social Care Health Care Administration Qualitätsmanagement Quality Management Six Sigma Verwaltung im Gesundheitswesen Wirtschaft u. Management
"The book is well-written and the authors use well versed descriptions, easy to read figures and tables, and industry-related examples and case studies to explain what can be very complex concepts and processes. This book would be a valuable resource for anyone in the field of medical device design." (Doody's Book Reviews, October 2008)
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