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Author: Basem El-Haik
Publisher: Wiley-Interscience
ISBN:
Category : Business & Economics
Languages : en
Pages : 564
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Book Description
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 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.
Author: Basem El-Haik
Publisher: Wiley-Interscience
ISBN:
Category : Business & Economics
Languages : en
Pages : 564
Get Book Here
Book Description
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 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.
Author: Basem El-Haik
Publisher: John Wiley & Sons
ISBN: 1118210417
Category : Medical
Languages : en
Pages : 556
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Book Description
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 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.
Author: Jose Justiniano
Publisher: CRC Press
ISBN: 0203485742
Category : Science
Languages : en
Pages : 129
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Book Description
Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it uses real world examples and sample plans to provide a practical how-to guide for implementation. This volume also links the Six Sigma philosophy with the FDA's Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. This book is an excellent tool for technical and scientific personnel to understand the realities of business and markets, to comply with stringent quality and safety standards, and to optimize the product realization process.
Author: Jose Justiniano
Publisher: CRC Press
ISBN: 1135506744
Category : Science
Languages : en
Pages : 113
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Book Description
Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it uses real world examples and sample plans to provide a practical how-to guide for implementation. This volume also links the Six Sigma philosophy with the FDA's Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. This book is an excellent tool for technical and scientific personnel to understand the realities of business and markets, to comply with stringent quality and safety standards, and to optimize the product realization process.
Author: Eric Maass
Publisher: Pearson Education
ISBN: 0137035918
Category :
Languages : en
Pages : 732
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Book Description
The Practical, Example-Rich Guide to Building Better Systems, Software, and Hardware with DFSS Design for Six Sigma (DFSS) offers engineers powerful opportunities to develop more successful systems, software, hardware, and processes. In Applying Design for Six Sigma to Software and Hardware Systems, two leading experts offer a realistic, step-by-step process for succeeding with DFSS. Their clear, start-to-finish roadmap is designed for successfully developing complex high-technology products and systems that require both software and hardware development. Drawing on their unsurpassed experience leading Six Sigma at Motorola, the authors cover the entire project lifecycle, from business case through scheduling, customer-driven requirements gathering through execution. They provide real-world examples for applying their techniques to software alone, hardware alone, and systems composed of both. Product developers will find proven job aids and specific guidance about what teams and team members need to do at every stage. Using this book’s integrated, systems approach, marketers, software professionals, and hardware developers can converge all their efforts on what really matters: addressing the customer’s true needs. Learn how to Ensure that your entire team shares a solid understanding of customer needs Define measurable critical parameters that reflect customer requirements Thoroughly assess business case risk and opportunity in the context of product roadmaps and portfolios Prioritize development decisions and scheduling in the face of resource constraints Flow critical parameters down to quantifiable, verifiable requirements for every sub-process, subsystem, and component Use predictive engineering and advanced optimization to build products that robustly handle variations in manufacturing and usage Verify system capabilities and reliability based on pilots or early production samples Master new statistical techniques for ensuring that supply chains deliver on time, with minimal inventory Choose the right DFSS tools, using the authors’ step-by-step flowchart If you’re an engineer involved in developing any new technology solution, this book will help you reflect the real Voice of the Customer, achieve better results faster, and eliminate fingerpointing. About the Web Site The accompanying Web site, sigmaexperts.com/dfss, provides an interactive DFSS flowchart, templates, exercises, examples, and tools.
Author: Richard C. Fries
Publisher: CRC Press
ISBN: 1420027948
Category : Medical
Languages : en
Pages : 490
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Book Description
As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.
Author: Greg Brue
Publisher: McGraw Hill Professional
ISBN: 0071425632
Category : Business & Economics
Languages : en
Pages : 209
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Book Description
THE BRIEFCASE BOOKS SERIEs Now translated into 11 languages! This reader-friendly, icon-rich series is must reading for all managers at every level All managers, whether brand new to their positions or well established in the corporate hierarchy, can use a little "brushing up" now and then. The skills-based Briefcase Books series is filled with ideas and strategies to help managers become more capable, efficient, effective, and valuable to their corporations. DESIGN FOR SIX SIGMA Six Sigma has revolutionized the ways in which companies meet and beat today's stringent quality expectations. But achieving Six Sigma results first requires Six Sigma building blocks. Design for Six Sigma unveils a systematic methodology for enabling the design of products, services, and processes to meet Six Sigma quality levels. Designed to be easily read and implemented, this concise Briefcase Book shows managers at all levels how to include Six Sigma at the earliest stages of virtually any manufacturing process. Here are DFSS's techniques for: Optimizing the design process to achieve Six Sigma performance Integrating Six Sigma from the outset of new product development Self-examinations, explanatory sidebars, and chapter-ending checklists
Author: Basem S. El-Haik
Publisher: John Wiley & Sons
ISBN: 1118074416
Category : Computers
Languages : en
Pages : 553
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Book Description
This proposal constitutes an algorithm of design applying the design for six sigma thinking, tools, and philosophy to software design. The algorithm will also include conceptual design frameworks, mathematical derivation for Six Sigma capability upfront to enable design teams to disregard concepts that are not capable upfront, learning the software development cycle and saving development costs. The uniqueness of this book lies in bringing all those methodologies under the umbrella of design and provide detailed description about how these methods, QFD, DOE, the robust method, FMEA, Design for X, Axiomatic Design, TRIZ can be utilized to help quality improvement in software development, what kinds of different roles those methods play in various stages of design and how to combine those methods to form a comprehensive strategy, a design algorithm, to tackle any quality issues in the design stage.
Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 1040063756
Category : Medical
Languages : en
Pages : 285
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Book Description
Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range o
Author: Nil
Publisher: Pearson Education India
ISBN: 9788131707265
Category :
Languages : en
Pages : 258
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Book Description
