Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2016-04-19 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
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.
Download or read book Design of Biomedical Devices and Systems Third Edition written by Paul H. King and published by CRC Press. This book was released on 2014-07-29 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize
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 508 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
Download or read book Handbook of Human Factors in Medical Device Design written by Matthew Bret Weinger and published by CRC Press. This book was released on 2010-12-13 with total page 822 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
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
Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
Download or read book Wireless Health written by Mehran Mehregany, PhD and published by AuthorHouse. This book was released on 2014-11-30 with total page 567 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book teaches the fundamental and practical knowledge necessary to advance wireless health technology and applications. It is suitable for both instructional and self-learning. The approach is an integrated, multidisciplinary treatment of the subject. Each chapter includes: Abstract, Learning Objectives, Introduction, Chapter Content, and Summary. This book is developed for graduate students and working professionals with technology, science and clinical backgrounds. It is also an effective informational resource for the broader community. The authors are practicing topic experts from academia and industry. The editor has developed a graduate course in the topic, which has been taught using informal drafts of this book since 2011. This book covers the following topics: About the Authors Foreword Preface Introduction Chapter 1 Introduction to Wireless Health Mehran Mehregany Chapter 2 Products, Services, and Business Models Mehran Mehregany and Vicki Smith Chapter 3 Physicians, Hospitals, and Clinics Kendal Williams Chapter 4 The Current US Health Care System David Gruber Chapter 5 Policy and Regulatory Aspects Dale Nordenberg Chapter 6 Personalized Medicine and Public Health Brigitte Piniewski, MD Chapter 7 Health Information Technology Rick Cnossen Chapter 8 Microsystems Masoud Roham Chapter 9 Wireless Communications Stein Lundby Chapter 10 Computing and Information John Sharp Chapter 11 Social Media and Health Keith Monrose Chapter 12 Electronic Instrumentation Christian Falconi Chapter 13 Medical Device Design Enrique Saldívar and Rajeev D. Rajan Chapter 14 Design for the Consumer Patient Srinivas Raghavan Chapter 15 Design for the Health Care Team Srinivas Raghavan Chapter 16 Leveraging the Power of Games Alan Price Chapter 17 Platforms, Interoperability, and Standards Rajeev D. Rajan Chapter 18 Steps Toward Security of Wireless Medical Devices Mike Ahmadi
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Download or read book Executing Design for Reliability Within the Product Life Cycle written by Ali Jamnia and published by CRC Press. This book was released on 2019-11-13 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: At an early stage of the development, the design teams should ask questions such as, "How reliable will my product be?" "How reliable should my product be?" And, "How frequently does the product need to be repaired / maintained?" To answer these questions, the design team needs to develop an understanding of how and why their products fails; then, make only those changes to improve reliability while remaining within cost budget. The body of available literature may be separated into three distinct categories: "theory" of reliability and its associated calculations; reliability analysis of test or field data – provided the data is well behaved; and, finally, establishing and managing organizational reliability activities. The problem remains that when design engineers face the question of design for reliability, they are often at a loss. What is missing in the reliability literature is a set of practical steps without the need to turn to heavy statistics. Executing Design for Reliability Within the Product Life Cycle provides a basic approach to conducting reliability-related streamlined engineering activities, balancing analysis with a high-level view of reliability within product design and development. This approach empowers design engineers with a practical understanding of reliability and its role in the design process, and helps design team members assigned to reliability roles and responsibilities to understand how to deploy and utilize reliability tools. The authors draw on their experience to show how these tools and processes are integrated within the design and development cycle to assure reliability, and also to verify and demonstrate this reliability to colleagues and customers.
Download or read book Fitting the Human written by Karl H.E. Kroemer and published by CRC Press. This book was released on 2017-03-16 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition undergraduate introductory textbook follows the motto of the previous versions: "Solid information, easy-to-read, easy to understand, easy to apply." The aim remains the same: "Human engineering" workplaces, tools, machinery, computers, lighting, shiftwork, work demands, the environment, officers, vehicles, the home – and everything else that we can design to fit the human. The new edition is up-to-date in content and language, in data and illustrations. Like previous versions, this book is for students and professionals in engineering, design, architecture, safety and management and to everybody else who wants to make work safe, efficient, satisfying, and even enjoyable.
Download or read book Achieving a Safe and Reliable Product written by E.F. "Bud" Gookins and published by Quality Press. This book was released on 2012-06-13 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is designed to be an easily read, high-level guide to inform the executive management and staff support functions of an organization how critical it is to develop a Product Liability Prevention System and the steps needed to establish an effective Product Safety Plan. It was created to inspire the reader to be aware that the product safety criteria must be a subset of the organization’s structure and built into the operation’s strategic plan. Internationally known quality consultant and lecturer Bud Gookins walks the reader though a series of product systems and design concepts that will enable the manufacturer and service organizations to establish a product safety and product liability prevention process that can be integrated into an existing structure. It discusses the key elements of a sound operational process, quality assurance, and reliability system approach to product safety. It will address product liability prevention initiatives, the salient points involved in justifying a product recall, and how to navigate though the recall of a defective product that reaches the field.
Download or read book Quality and Reliability Engineering Recent Trends and Future Directions written by Boby John and published by Allied Publishers. This book was released on 2013-04-16 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: International conference supported by Indian Statistical Institute, held at Bangalore, 20-22 December, 2011; selected papers.
Download or read book Usability Testing of Medical Devices written by Michael E. Wiklund, P.E. and published by CRC Press. This book was released on 2015-12-23 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h
Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-01-01 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
