Medical Device Design For Six Sigma

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Medical Device Design for Six Sigma

Author : Basem El-Haik
Publisher : John Wiley & Sons
ISBN 13 : 1118210417
Total Pages : 528 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Medical Device Design for Six Sigma by : Basem El-Haik

Download or read book Medical Device Design for Six Sigma written by Basem El-Haik and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Six Sigma for Medical Device Design

Author : Jose Justiniano
Publisher : CRC Press
ISBN 13 : 1135506744
Total Pages : 113 pages
Book Rating : 4.1/5 (355 download)

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Book Synopsis Six Sigma for Medical Device Design by : Jose Justiniano

Download or read book Six Sigma for Medical Device Design written by Jose Justiniano and published by CRC Press. This book was released on 2004-11-15 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Six Sigma for Medical Device Design

Author : Jose Justiniano
Publisher : CRC Press
ISBN 13 : 0203485742
Total Pages : 152 pages
Book Rating : 4.2/5 (34 download)

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Book Synopsis Six Sigma for Medical Device Design by : Jose Justiniano

Download or read book Six Sigma for Medical Device Design written by Jose Justiniano and published by CRC Press. This book was released on 2004-11-15 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1420027948
Total Pages : 490 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Reliable Design of Medical Devices by : Richard C. Fries

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Applying Design for Six Sigma to Software and Hardware Systems

Author : Eric Maass
Publisher : Pearson Education
ISBN 13 : 0137035918
Total Pages : 543 pages
Book Rating : 4.1/5 (37 download)

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Book Synopsis Applying Design for Six Sigma to Software and Hardware Systems by : Eric Maass

Download or read book Applying Design for Six Sigma to Software and Hardware Systems written by Eric Maass and published by Pearson Education. This book was released on 2009-08-19 with total page 543 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Device Design

Author :
Publisher : Academic Press
ISBN 13 : 0123919436
Total Pages : 369 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Medical Device Design by :

Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Medical Device Quality Management Systems

Author : Susanne Manz
Publisher : Academic Press
ISBN 13 : 0128142227
Total Pages : 294 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Medical Device Quality Management Systems by : Susanne Manz

Download or read book Medical Device Quality Management Systems written by Susanne Manz and published by Academic Press. This book was released on 2018-09-27 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans

Design for Six Sigma

Author : Greg Brue
Publisher : McGraw Hill Professional
ISBN 13 : 0071425632
Total Pages : 209 pages
Book Rating : 4.0/5 (714 download)

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Book Synopsis Design for Six Sigma by : Greg Brue

Download or read book Design for Six Sigma written by Greg Brue and published by McGraw Hill Professional. This book was released on 2003-02-22 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Software Design for Six Sigma

Author : Basem S. El-Haik
Publisher : John Wiley & Sons
ISBN 13 : 1118074416
Total Pages : 553 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Software Design for Six Sigma by : Basem S. El-Haik

Download or read book Software Design for Six Sigma written by Basem S. El-Haik and published by John Wiley & Sons. This book was released on 2011-02-16 with total page 553 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Design of Biomedical Devices and Systems, 4th edition

Author : Paul H. King
Publisher : CRC Press
ISBN 13 : 0429786050
Total Pages : 725 pages
Book Rating : 4.4/5 (297 download)

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Book Synopsis Design of Biomedical Devices and Systems, 4th edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems, 4th edition written by Paul H. King and published by CRC Press. This book was released on 2018-10-03 with total page 725 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes

Design for Six Sigma in Product and Service Development

Author : Elizabeth A. Cudney
Publisher : CRC Press
ISBN 13 : 1439866406
Total Pages : 444 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Design for Six Sigma in Product and Service Development by : Elizabeth A. Cudney

Download or read book Design for Six Sigma in Product and Service Development written by Elizabeth A. Cudney and published by CRC Press. This book was released on 2016-04-19 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: Real-world examples and hands-on experience are invaluable resources when learning how to use new methods and tools, whether in training or in a classroom. Yet there are very few books on Design for Six Sigma (DFSS) that provide the practical knowledge required to be up and running quickly. Until now. Design for Six Sigma in Product and Service Development: Applications and Case Studies provides step-by-step analysis and practical guidance on how to apply DFSS in product and service development. The book discusses the DFSS roadmap and how it is linked to methodologies, including organizational leadership, product development, system integration, critical parameter management, voice of the customer, quality function deployment, and concept generation. The chapter authors provide real-world case studies that demonstrate how the application of DFSS has significantly improved meeting customer requirements. They follow the Identify-Define-Design-Optimize-Validate (IDDOV) structure for new product or service development. Examples of tools covered include Quality Function Deployment, Voice of the Customer, Pugh Concept Selection, Ideal Function, Failure Modes and Effects Analysis, Reliability, Measurement Systems Analysis, Regression Analysis, and Capability Studies, among others. Clearly outlining the tools and how to integrate them for robust product and service design, the case studies can be used by industry professionals and academics to learn how to apply DFSS. The book gives you hands-on experience in a safe environment, where experienced Black Belts and Master Black Belts act as mentors and prepare you to touch actual data and make decisions when embarking on real-world projects. Even after you’ve mastered the techniques, the breadth and depth of coverage contained in this book will make it a vital part of your toolkit.

Design for Six Sigma in Technology and Product Development

Author : Clyde M. Creveling
Publisher : Prentice Hall Professional
ISBN 13 : 0132797240
Total Pages : 1170 pages
Book Rating : 4.1/5 (327 download)

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Book Synopsis Design for Six Sigma in Technology and Product Development by : Clyde M. Creveling

Download or read book Design for Six Sigma in Technology and Product Development written by Clyde M. Creveling and published by Prentice Hall Professional. This book was released on 2002-10-25 with total page 1170 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses many new topical areas for the development of 6 Sigma performance. The text is structured to demonstrate how 6 Sigma methods can be used as a very powerful tool within System Engineering and integration evaluations to help enable the process of Critical Parameter Management. The case studies and examples used throughout the book come from recent successful applications of the material developed in the text.

Implementing Design For Six Sigma: A Leader'S Guide (With Cd)

Author : Nil
Publisher : Pearson Education India
ISBN 13 : 9788131707265
Total Pages : 258 pages
Book Rating : 4.7/5 (72 download)

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Book Synopsis Implementing Design For Six Sigma: A Leader'S Guide (With Cd) by : Nil

Download or read book Implementing Design For Six Sigma: A Leader'S Guide (With Cd) written by Nil and published by Pearson Education India. This book was released on 2007-09 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Implementing Design for Six Sigma

Author : Georgette Belair
Publisher : Quality Press
ISBN 13 : 0873894065
Total Pages : 257 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Implementing Design for Six Sigma by : Georgette Belair

Download or read book Implementing Design for Six Sigma written by Georgette Belair and published by Quality Press. This book was released on 2007-01-02 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Have your company’s products achieved what you hoped for – rapid customer uptake, high sales volume and revenue/profit? Can you produce them at high Sigma-levels for Critical to Quality requirements, resulting in high customer satisfaction and low return/warranty costs? Authors Belair and O’Neill will help you understand how your current new-product development process is performing by diagnosing its strengths and weaknesses, and then planning and implementing changes to improve your organization’s ability to deliver Six Sigma designs!!--nl--The main goal of Implementing Design for Six Sigma is to provide you a game plan to help you “move the ball down the field” – from your current product development world to one where DFSS has been embraced as a working part of your processes and culture. Whether the products you develop are made of metal and plastic, or money and mutual funds, this book will help you improve your development process so that you may deliver better products and services that your customers will want and want to pay for. From tangible products like cars and cough syrup to service products like mortgages and retirement plans, if you dig deeply into your new-product development process and follow the guidelines in this book, you can and will implement major improvements.-

Six Sigma Software Quality Improvement

Author : Vic Nanda
Publisher : McGraw Hill Professional
ISBN 13 : 0071700633
Total Pages : 635 pages
Book Rating : 4.0/5 (717 download)

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Book Synopsis Six Sigma Software Quality Improvement by : Vic Nanda

Download or read book Six Sigma Software Quality Improvement written by Vic Nanda and published by McGraw Hill Professional. This book was released on 2011-03-08 with total page 635 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proven techniques for improving software and process quality with Six Sigma This practical, in-depth guide explains how to apply Six Sigma to solve common product and process improvement challenges in the software and IT industry. Six Sigma Software Quality Improvement covers Define, Measure, Analyze, Improve, and Control (DMAIC), Lean Six Sigma, Design for Six Sigma (DFSS), and Define, Measure, Analyze, Design, and Verify (DMADV). Featuring more than 20 success stories from Motorola, IBM, Cisco, Seagate, Xerox, Thomson Reuters, TCS, EMC, Infosys, and Convergys, the book offers first-hand accounts of corporate Six Sigma programs and explains how these companies are successfully leveraging Six Sigma for software process and quality improvement. The success stories reveal how: Motorola minimized business risk before changing business-critical applications TCS improved fraud detection for a global bank Infosys improved software development productivity for a large multinational bank IBM reduced help desk escalations and overhead activities EMC improved development productivity Motorola realized significant cost avoidance by streamlining processes and project documentation Xerox achieved high-speed product development Seagate reduced application downtime and improved availability to 99.99% Cisco successfully reinvented its Six Sigma program Convergys injected Six Sigma into the company's DNA Thomson Reuters' Six Sigma program gathered significant momentum in a short time Six Sigma was successfully applied in many other projects for defect reduction, cycle time reduction, productivity improvement, and more

What is Design for Six Sigma

Author : Roland R. Cavanagh
Publisher : McGraw Hill Professional
ISBN 13 : 0071454993
Total Pages : 97 pages
Book Rating : 4.0/5 (714 download)

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Book Synopsis What is Design for Six Sigma by : Roland R. Cavanagh

Download or read book What is Design for Six Sigma written by Roland R. Cavanagh and published by McGraw Hill Professional. This book was released on 2005-02-20 with total page 97 pages. Available in PDF, EPUB and Kindle. Book excerpt: What Is Design for Six Sigma? reveals how to use DFSS to design new products, services, and processes so that quality problems can be solved before they ever start. Topics include: How to design new products and processes The DMADOV implementation process (Define, Measure, Analyze, Design, Optimize, and Verify) How to redesign existing processes and services

Design of Biomedical Devices and Systems Second edition

Author : Paul H. King
Publisher : CRC Press
ISBN 13 : 1439878072
Total Pages : 424 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Design of Biomedical Devices and Systems Second edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems Second edition written by Paul H. King and published by CRC Press. This book was released on 2008-08-22 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This