Medical Device Design for Six Sigma
A Roadmap for Safety and Effectiveness
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Medical Device Design for Six Sigma by Basem El-Haik
Book DescriptionThe 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 with real-world examples, this guide:* 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 Providing both a road map and a toolbox, this is a hands-on reference for medical device product development practitioners, product/service development engineers and architects, DFSS and Six Sigma trainees and trainers, middle management, engineering team leaders, quality engineers and quality consultants, and graduate students in biomedical engineering.
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Book DetailsISBN: 9780470168615
(245mm x 163mm x 30mm)
Publisher: John Wiley and Sons Ltd
Publish Date: 23-May-2008
Country of Publication: United States
Books By Author Basem El-Haik
Software Design for Six Sigma, Hardback (October 2010)
As the first to include the American Society for Quality s research , Software Design for Six Sigma provides design methodologies and various methods, like QFD, DOE, the robust method, FMEA, Design for X, Axiomatic Design, and TRIZ.
Simulation-Based Lean Six-Sigma and Design for Six-Sigma, Hardback (October 2006)
This is the first book to completely cover the whole body of knowledge of Six Sigma and Design for Six Sigma with Simulation Methods as outlined by the American Society for Quality. Both simulation and contemporary Six Sigma methods are explained in detail with practical examples that help understanding of the key features of the design methods.
Service Design for Six Sigma, Hardback (July 2005)
Six Sigma is a disciplined, data-driven approach and methodology for eliminating defects in any process, from manufacturing to transactional and from product to service. This interesting new text documents how service and process design and redesign are typically approached.
Axiomatic Quality, Hardback (May 2005)» View all books by Basem El-Haik
Axiomatic Quality and Reliability aids you in developing design concepts, processes and methodologies that eliminate or reduce both conceptual and operational types of weaknesses and help design teams in producing systems that operate at high quality levels for each of their design requirements.
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Author Biography - Basem El-Haik
Basem S. El-Haik, PhD, is the CEO and President of Six Sigma Professionals, Inc. (www.sixsigmapi.com) in Canton, Michigan, and the author of many bestselling books on Design for Six Sigma. Dr. El-Haik is well known in the DFSS domain and has been a featured speaker at many technical conferences. He has seventeen years of experience in contemporary design and quality engineering methods and has trained, certified, coached, and monitored over 600 belts (Green Belts, Black Belts, and Master Belts) in DFSS and Six Sigma in both tracks: product and service (transactional). firstname.lastname@example.org Khalid S. Mekki is a Quality Manager at Baxter Healthcare Corporation, where he has served in various capacities since 2001. He is working toward his PhD in industrial engineering at the University of Illinois at Chicago. Khalid holds a master's degree in mechanical/quality engineering and a bachelor's degree in mechanical engineering. He has led and completed numerous Design for Six Sigma projects.
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