June 13, 2021

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Reliable Design of Medical Devices, Third Edition

Reliable Design of Medical Devices, Third Edition
Author : Richard C. Fries
Publisher : CRC Press
Release Date : 2012-09-06
Category : Medical
Total pages :501
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As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.

Reliable Design of Medical Devices

Reliable Design of Medical Devices
Author : Richard C. Fries
Publisher : CRC Press
Release Date : 1997-01-30
Category : Medical
Total pages :728
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Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.

Reliable Design of Medical Devices, Second Edition

Reliable Design of Medical Devices, Second Edition
Author : Richard C. Fries
Publisher : CRC Press
Release Date : 2005-11-21
Category : Medical
Total pages :504
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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.

Reliable Design of Medical Devices

Reliable Design of Medical Devices
Author : Richard C. Fries
Publisher : CRC Press
Release Date : 2016-04-19
Category : Medical
Total pages :501
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As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable D

Biomaterials in the Design and Reliability of Medical Devices

Biomaterials in the Design and Reliability of Medical Devices
Author : Michael N. Helmus
Publisher : Springer
Release Date : 2003-01-31
Category : Technology & Engineering
Total pages :226
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This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.

Reliability and Regulatory Compliance Design for Medical Devices

Reliability and Regulatory Compliance Design for Medical Devices
Author : Reinaldo Perez
Publisher : Academic Press
Release Date : 2002-06
Category : Medical
Total pages :350
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This text addresses all of the major design considerations in making a device reliable including electromagnetic interference, noise and environmental considerations such as temperature, radiation and moisture. The second major issue is the ability of the device to meet with the codes, standards and regulations necessary for approval. This text addresses both the reliability and the regulations from the standpoint of the design.

Design of Biomedical Devices and Systems, Second Edition

Design of Biomedical Devices and Systems, Second Edition
Author : Paul H. King,Richard C. Fries
Publisher : CRC Press
Release Date : 2008-08-22
Category : Medical
Total pages :422
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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 edition of a bestselling textbook utilizes a strong design perspective to provide designers with a thorough overview of the field, including topics related to databases, process analysis, and device improvement. Covers All Necessary Design Aspects for Advanced Biomedical Projects Designed primarily for senior bioengineering students in the formative stages of planning their design project, Design of Biomedical Devices and Systems is also beneficial to graduate students in the field and practitioners working with medical devices. This standard-setting resource includes: A variety of open-ended design problems and examples An overview of device definitions and reliability A discussion of testing and hardware verification and validation principles Detailed photographs and illustrations within each chapter Systematic approaches to device development and maintenance are mandated to ensure safe and effective devices for the patient, an economical and competitive success for the manufacturer, and a reliable, cost-effective investment for the user. This authoritative textbook answers the call. A solutions manual is available for instructors wishing to convert this reference to classroom use.

Medical Device Design for Six Sigma

Medical Device Design for Six Sigma
Author : Basem El-Haik,Khalid S. Mekki
Publisher : Wiley-Interscience
Release Date : 2008-04-25
Category : Medical
Total pages :528
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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.

Practical Design Control Implementation for Medical Devices

Practical Design Control Implementation for Medical Devices
Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Release Date : 2019-08-30
Category :
Total pages :232
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Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

Medical Device and Equipment Design

Medical Device and Equipment Design
Author : Michael E. Wiklund
Publisher : CRC Press
Release Date : 1995-02-15
Category : Technology & Engineering
Total pages :398
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The key to profitability and success in both the medical device and the equipment markets often relates to how easy your products are to use. User acceptance and preference frequently is dependent upon ergonomic design. Medical Device and Equipment Design helps you enhance your product design, maximize user acceptance, and minimize potential problems in the marketplace. It provides practical guidance on how to plan and incorporate ergonomic design principles into medical devices and equipment so users intuitively feel comfortable with the product. Design engineers, usability and reliability engineers, software programmers, documentation specialists, product managers, quality engineers, and market/product managers will find this text invaluable in getting usability built into products from the very beginning.

Handbook of Medical Device Design

Handbook of Medical Device Design
Author : Richard C. Fries
Publisher : CRC Press
Release Date : 2019-08-15
Category : Medical
Total pages :774
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First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Encyclopedia of Medical Devices and Instrumentation

Encyclopedia of Medical Devices and Instrumentation
Author : John G. Webster
Publisher : Wiley-Interscience
Release Date : 2006-04-07
Category : Science
Total pages :6
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The articles in The Encyclopedia of Medical Devices and Instrumentation focus on what is currently useful or is likely to be useful in future medicine. They answer the question, What are the branches of medicine and how does technology assist each of them? Articles focus on the practice of medicine that is assisted by devices, rather than including, for example, the use of drugs to treat disease. The title is the only resource on the market dealing with the subject in encyclopedic detail. * Accessible to practitioners with a broad range of backgrounds from students to researchers and physicians * Articles cover the latest developments such as nanotechnology, fiber optics, and signal processing

Practical Design Control Implementation for Medical Devices

Practical Design Control Implementation for Medical Devices
Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Release Date : 2003-03-12
Category : Technology & Engineering
Total pages :232
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Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

Design of Biomedical Devices and Systems, Third Edition

Design of Biomedical Devices and Systems, Third Edition
Author : Paul H. King,Richard C. Fries,Arthur T. Johnson
Publisher : CRC Press
Release Date : 2014-07-29
Category : Medical
Total pages :515
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Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.

Medical Device Reliability and Associated Areas

Medical Device Reliability and Associated Areas
Author : B.S. Dhillon
Publisher : CRC Press
Release Date : 2000-03-29
Category : Technology & Engineering
Total pages :264
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Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques. Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field. It addresses a variety of topics related - directly and indirectly - to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.