Reliability And Regulatory Compliance Design For Medical Devices
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| Author | : Richard C. Fries |
| Publisher | : CRC Press |
| Total Pages | : 490 |
| Release | : 2005-11-21 |
| Genre | : Medical |
| ISBN | : 1420027948 |
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 | : Michael Cheng |
| Publisher | : World Health Organization |
| Total Pages | : 54 |
| Release | : 2003-09-16 |
| Genre | : Medical |
| ISBN | : 9241546182 |
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
| Author | : Wayne A. Taylor |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2017 |
| Genre | : |
| ISBN | : 9780963512291 |
| Author | : Richard C. Fries |
| Publisher | : CRC Press |
| Total Pages | : 505 |
| Release | : 2012-09-06 |
| Genre | : Medical |
| ISBN | : 1439894914 |
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.
| Author | : Dev G. Raheja |
| Publisher | : John Wiley & Sons |
| Total Pages | : 494 |
| Release | : 2006-06-23 |
| Genre | : Technology & Engineering |
| ISBN | : 0470009411 |
The Second Edition features new content, examples,methods, techniques, and best practices Assurance Technologies Principles and Practices is based on the assertion that safety is not a cost, but an excellent investment. According to the authors, more than sixty percent of problems in complex systems arise from incomplete, vague, and poorly written specifications. In keeping with the authors' passion for safety, the text is dedicated to uniting the gamut of disciplines that are essential for effective design applying assurance technology principles, including system safety, reliability, maintainability, human engineering, quality, logistics, software integrity, and system integration. Readers familiar with the first edition of this text will recognize all the hallmarks that have made it a classic in its field. The Second Edition features a host of new examples, methods, techniques, and best practices to bring the text fully up to date with the state of the art in assurance technology. Much new content has been added as well, including four new chapters: Managing Safety-Related Risks Statistical Concepts, Loss Analysis, and Safety-Related Applications Models, Concepts, and Examples: Applying Scenario-Driven Hazard Analysis Automation, Computer, and Software Complexities The text begins with an introduction and overview of assurance technology. Next, readers are provided with fundamental statistical concepts. The chapters that follow explore in depth the approaches and disciplines that make up assurance technology applications. Each chapter is organized into major phases-design, manufacturing, test, and use phase-that help readers understand both how and when to apply particular measures. Throughout the text, readers discover detailed examples that prepare them to manage real-world challenges. References and further reading are provided at the end of each chapter leading to more in-depth discussion on specialized topics. With its extensive use of examples and highly structured approach, this is an excellent course book for students in industrial engineering, systems engineering, risk engineering, and other assurance technology domains. Design and system engineers as well as safety professionals will find the material essential in troubleshooting complex projects and ensuring product, process, and system safety.
| Author | : B.S. Dhillon |
| Publisher | : CRC Press |
| Total Pages | : 265 |
| Release | : 2000-03-29 |
| Genre | : Business & Economics |
| ISBN | : 1420042238 |
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,
| Author | : Richard C. Fries |
| Publisher | : CRC Press |
| Total Pages | : 504 |
| Release | : 1998-08-11 |
| Genre | : Medical |
| ISBN | : 9780824701772 |
"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."
| Author | : Richard C. Fries |
| Publisher | : CRC Press |
| Total Pages | : 450 |
| Release | : 2019-08-15 |
| Genre | : Medical |
| ISBN | : 1000696952 |
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.
| Author | : Michael J. McGrath |
| Publisher | : Apress |
| Total Pages | : 321 |
| Release | : 2014-01-23 |
| Genre | : Computers |
| ISBN | : 1430260149 |
Sensor Technologies: Healthcare, Wellness and Environmental Applications explores the key aspects of sensor technologies, covering wired, wireless, and discrete sensors for the specific application domains of healthcare, wellness and environmental sensing. It discusses the social, regulatory, and design considerations specific to these domains. The book provides an application-based approach using real-world examples to illustrate the application of sensor technologies in a practical and experiential manner. The book guides the reader from the formulation of the research question, through the design and validation process, to the deployment and management phase of sensor applications. The processes and examples used in the book are primarily based on research carried out by Intel or joint academic research programs. “Sensor Technologies: Healthcare, Wellness and Environmental Applications provides an extensive overview of sensing technologies and their applications in healthcare, wellness, and environmental monitoring. From sensor hardware to system applications and case studies, this book gives readers an in-depth understanding of the technologies and how they can be applied. I would highly recommend it to students or researchers who are interested in wireless sensing technologies and the associated applications.” Dr. Benny Lo Lecturer, The Hamlyn Centre, Imperial College of London “This timely addition to the literature on sensors covers the broad complexity of sensing, sensor types, and the vast range of existing and emerging applications in a very clearly written and accessible manner. It is particularly good at capturing the exciting possibilities that will occur as sensor networks merge with cloud-based ‘big data’ analytics to provide a host of new applications that will impact directly on the individual in ways we cannot fully predict at present. It really brings this home through the use of carefully chosen case studies that bring the overwhelming concept of 'big data' down to the personal level of individual life and health.” Dermot Diamond Director, National Centre for Sensor Research, Principal Investigator, CLARITY Centre for Sensor Web Technologies, Dublin City University "Sensor Technologies: Healthcare, Wellness and Environmental Applications takes the reader on an end-to-end journey of sensor technologies, covering the fundamentals from an engineering perspective, introducing how the data gleaned can be both processed and visualized, in addition to offering exemplar case studies in a number of application domains. It is a must-read for those studying any undergraduate course that involves sensor technologies. It also provides a thorough foundation for those involved in the research and development of applied sensor systems. I highly recommend it to any engineer who wishes to broaden their knowledge in this area!" Chris Nugent Professor of Biomedical Engineering, University of Ulster
| Author | : B.S. Dhillon |
| Publisher | : CRC Press |
| Total Pages | : 416 |
| Release | : 1999-06-18 |
| Genre | : Technology & Engineering |
| ISBN | : 9781420050141 |
As engineering systems become more and more complex, industry has recognized the importance of system and product reliability and places ever increasing emphasis on it during the design phase. Despite its efforts, however, industry continues to lose billions of dollars each year because of unexpected system failures. Therefore, it becomes increasingly important for designers and engineers to have a solid grounding in reliability engineering and keep abreast of new developments and research results.
