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Medical Device Design For Six Sigma

Author: Basem El-Haik
Publisher: John Wiley & Sons
ISBN: 1118210417
Size: 11.40 MB
Format: PDF, Kindle
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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.

Six Sigma For Medical Device Design

Author: Jose Justiniano
Publisher: CRC Press
ISBN: 0203485742
Size: 13.74 MB
Format: PDF, Kindle
View: 6451
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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 the same for the medical devices field. Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field. Authored by experienced professionals, it provides a how-to guide to implementing such a program while dispelling commonly held myths regarding deployment and adoption. This volume also links the philosophy with the FDA's Design Control regulation, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. For management wishing to launch innovative medical devices as quickly as possible, this text establishes a way to align all levels of the organization to produce a high level of development that is both timely and compliant. It is also an excellent tool for technical and scientific personnel to understand the realities of business and markets and to optimize the product realization process.

Biomedical Devices

Author: Tŭgrul ?zel
Publisher: John Wiley & Sons
ISBN: 1118478924
Size: 43.24 MB
Format: PDF, ePub, Docs
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Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

Six Sigma For Medical Device Design

Author: Jose Justiniano
Publisher: CRC Press
ISBN: 0203485742
Size: 44.69 MB
Format: PDF, Kindle
View: 1730
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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 the same for the medical devices field. Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field. Authored by experienced professionals, it provides a how-to guide to implementing such a program while dispelling commonly held myths regarding deployment and adoption. This volume also links the philosophy with the FDA's Design Control regulation, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. For management wishing to launch innovative medical devices as quickly as possible, this text establishes a way to align all levels of the organization to produce a high level of development that is both timely and compliant. It is also an excellent tool for technical and scientific personnel to understand the realities of business and markets and to optimize the product realization process.

Design For Six Sigma

Author: Greg Brue
Publisher: McGraw Hill Professional
ISBN: 9780071425636
Size: 69.55 MB
Format: PDF, ePub
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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

Service Design For Six Sigma

Author: Basem El-Haik
Publisher: John Wiley & Sons
ISBN: 0471744700
Size: 33.44 MB
Format: PDF
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A roadmap to consistent, high-quality service for any organization A service is typically something created to serve a paying customer, whether internal or external. Some services consist of several processes linked together while others consist of a single process. This book introduces Design for Six Sigma (DFSS), an easy-to-master, yet highly effective data-driven method that prevents defects in any type of service process. The particular focus of this publication is service DFSS, which leads to what the authors term "a whole quality business," one that takes a proactive stance and gets things right the first time. Not only does the whole quality business produce a high-quality product and offer high-quality services, but it also operates at lower cost and higher efficiency, throughout the entire life cycle, than its competitors because all the links in the supply chain are optimized. Following a detailed overview that sets forth the basic premise and key concepts of service DFSS, the authors offer all the information and tools needed to take advantage of service DFSS within their own organizations, including: * Clear and in-depth coverage of the philosophical, organizational, and technical aspects of service DFSS * Step-by-step roadmap of the entire service DFSS deployment and execution process * Full discussions of all the key methods involved in service DFSS, including axiomatic design, design for X, the theory of inventive problem solving (TRIZ), transfer function, design scorecards, and Taguchi's method * Practical, illustrative examples that demonstrate how the theory is put into practice * Assistance in developing the necessary skills in applying DFSS in organizational settings Problems and their solutions are provided at the end of each chapter to help readers grasp the key concepts they need to move forward in the text. Acclaro DFSS Light(r), a Java-based software package that implements axiomatic design processes discussed in Chapter Eight, is available for download from an accompanying Wiley ftp site. Acclaro DFSS Light(r) is a software product of Axiomatic Design Solutions, Inc. This book is ideal as a reference to service DFSS for corporate executives, quality control managers, and process engineers, or as a complete training manual for DFSS teams. It is also a superior textbook for graduate students in management, operations, and quality assurance.

Medical Device Quality Assurance And Regulatory Compliance

Author: Richard C. Fries
Publisher: CRC Press
ISBN: 148227003X
Size: 26.28 MB
Format: PDF, ePub
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"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

Lean Six Sigma For Small And Medium Sized Enterprises

Author: Jiju Antony
Publisher: CRC Press
ISBN: 1482260093
Size: 30.17 MB
Format: PDF, ePub, Docs
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It is no secret that Lean Six Sigma (LSS) is not as popular with small and medium-sized enterprises (SMEs) as it is with larger ones. However, many SMEs are suppliers to larger entities who are pushing for superior quality and world-class process efficiencies from suppliers. Lean Six Sigma for Small and Medium Sized Enterprises: A Practical Guide provides a roadmap for the successful implementation and deployment of LSS in SMEs. It includes five real-world case studies that demonstrate how LSS tools have been successfully integrated into LSS methodology. Simplifying the terminology and methodology of LSS, this book makes the implementation process accessible. Supplies a general introduction to continuous improvement initiatives in SMEs Identifies the key phases in the introduction and development of LSS initiatives within an SME Details the most powerful LSS tools and techniques that can be used in an SME environment Provides tips on how to make the project selection process more successful This book covers the fundamental challenges and common pitfalls that can be avoided with successful introduction and deployment of LSS in the context of SMEs. Systematically guiding you through the application of the Six Sigma methodology for problem solving, the book devotes separate chapters to the most appropriate tools and techniques that can be useful in each stage of the methodology. Keeping the required math and statistics to a minimum, this practical guide will help you to deploy LSS as your prime methodology for achieving and sustaining world-class efficiency and effectiveness of critical business processes.

Design For Lean Six Sigma

Author: Rajesh Jugulum
Publisher: John Wiley & Sons
ISBN: 9780470631690
Size: 22.72 MB
Format: PDF, ePub, Mobi
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Design for Lean Six Sigmais the only book that employs a "road-map" approach to DFSS, which allows corporate management to understand where they are in the process and to integrate DFSS methodology more fully into their overall business strategy. This is a similar approach to that used by Forrest Breyfogle in his successful book: "Implementing Six Sigma, 2E". This approach will allow corporate management to understand where they are in the process and to integrate DFSS methodology more fully into the overall business strategy. Another important aspect of this book is its coverage of DFSS implementation in a broad range of industries including service and manufacturing, plus the use of actual cases throughout.