Reliable Design of Medical Devices

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Release : 2005-11-21
Genre : Medical
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Book Rating : 948/5 ( reviews)

Reliable Design of Medical Devices - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Reliable Design of Medical Devices write by Richard C. Fries. This book was released on 2005-11-21. Reliable Design of Medical Devices available in PDF, EPUB and Kindle. 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, Third Edition

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Release : 2012-09-06
Genre : Medical
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Book Rating : 914/5 ( reviews)

Reliable Design of Medical Devices, Third Edition - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Reliable Design of Medical Devices, Third Edition write by Richard C. Fries. This book was released on 2012-09-06. Reliable Design of Medical Devices, Third Edition available in PDF, EPUB and Kindle. 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.

Handbook of Human Factors in Medical Device Design

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Release : 2010-12-13
Genre : Technology & Engineering
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Book Rating : 510/5 ( reviews)

Handbook of Human Factors in Medical Device Design - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Handbook of Human Factors in Medical Device Design write by Matthew Bret Weinger. This book was released on 2010-12-13. Handbook of Human Factors in Medical Device Design available in PDF, EPUB and Kindle. Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance

Engineering Open-Source Medical Devices

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Release : 2022-02-23
Genre : Medical
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Book Rating : 63X/5 ( reviews)

Engineering Open-Source Medical Devices - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Engineering Open-Source Medical Devices write by Arti Ahluwalia. This book was released on 2022-02-23. Engineering Open-Source Medical Devices available in PDF, EPUB and Kindle. This book focuses on the challenges and potentials of open source and collaborative design approaches and strategies in the biomedical field. It provides a comprehensive set of good practices and methods for making these safe, innovative and certifiable biomedical devices reach patients and provide successful solutions to healthcare issues. The chapters are sequenced to follow the complete lifecycle of open source medical technologies. The information provided is eminently practical, as it is supported by real cases of study, in which collaboration among medical professionals, engineers and technicians, patients and patient associations, policy makers, regulatory bodies, and citizens has proven beneficial. The book is also supported by an online infrastructure, UBORA, through which open-source medical devices can be collaboratively developed and shared for the democratization of medical technology and for promoting accessible biomedical engineering education.

Guidelines for Failure Mode and Effects Analysis (FMEA), for Automotive, Aerospace, and General Manufacturing Industries

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Release : 2003-03-03
Genre : Technology & Engineering
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Book Rating : 681/5 ( reviews)

Guidelines for Failure Mode and Effects Analysis (FMEA), for Automotive, Aerospace, and General Manufacturing Industries - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Guidelines for Failure Mode and Effects Analysis (FMEA), for Automotive, Aerospace, and General Manufacturing Industries write by Dyadem Press. This book was released on 2003-03-03. Guidelines for Failure Mode and Effects Analysis (FMEA), for Automotive, Aerospace, and General Manufacturing Industries available in PDF, EPUB and Kindle. These guidelines form a comprehensive overview of Failure Mode and Effects Analysis (FMEA) and examines why FMEA has become a powerful and respected analytical technique for effectively managing and reducing risks. Readers learn how to use FMEA throughout the life cycles of their product to improve customer satisfaction and assure safety and regulatory compliance. They will obtain sound advice on selecting a study team, setting up and conducting a study, and analyzing the results. Other topics include Failure Mode, Effects, and Criticality Analysis, Risk Management Planning, Advanced Quality Planning, Product Quality Control Plans, and Dynamic Control Plans.