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 Reliable Design of Medical Devices Third Edition written by Richard C. Fries and published by CRC Press. This book was released on 2012-09-06 with total page 505 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 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.
Download or read book Designing Usability into Medical Products written by Michael E. Wiklund and published by CRC Press. This book was released on 2005-02-11 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range o
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 Engineering Open Source Medical Devices written by Arti Ahluwalia and published by Springer Nature. This book was released on 2022-02-23 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 Reliability and Regulatory Compliance Design for Medical Devices written by Reinaldo Perez and published by Academic Press. This book was released on 2002-06 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 709 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 The Medical Device R D Handbook written by Theodore R. Kucklick and published by CRC Press. This book was released on 2005-11-21 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha
Download or read book Guidelines for Failure Mode and Effects Analysis FMEA for Automotive Aerospace and General Manufacturing Industries written by Dyadem Press and published by CRC Press. This book was released on 2003-03-03 with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Design for Reliability written by Dev G. Raheja and published by John Wiley & Sons. This book was released on 2012-07-20 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: A unique, design-based approach to reliability engineering Design for Reliability provides engineers and managers with a range of tools and techniques for incorporating reliability into the design process for complex systems. It clearly explains how to design for zero failure of critical system functions, leading to enormous savings in product life-cycle costs and a dramatic improvement in the ability to compete in global markets. Readers will find a wealth of design practices not covered in typical engineering books, allowing them to think outside the box when developing reliability requirements. They will learn to address high failure rates associated with systems that are not properly designed for reliability, avoiding expensive and time-consuming engineering changes, such as excessive testing, repairs, maintenance, inspection, and logistics. Special features of this book include: A unified approach that integrates ideas from computer science and reliability engineering Techniques applicable to reliability as well as safety, maintainability, system integration, and logistic engineering Chapters on design for extreme environments, developing reliable software, design for trustworthiness, and HALT influence on design Design for Reliability is a must-have guide for engineers and managers in R&D, product development, reliability engineering, product safety, and quality assurance, as well as anyone who needs to deliver high product performance at a lower cost while minimizing system failure.
Download or read book Biomedical Devices written by Tugrul Özel and published by John Wiley & Sons. This book was released on 2016-10-24 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Materials and Coatings for Medical Devices written by and published by ASM International. This book was released on 2009-01-01 with total page 453 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Materials Information Society, MPMD-Materials and Processes for Medical Devices."
Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Download or read book Design of Biomedical Devices and Systems written by Dragan Primorac and published by CRC Press. This book was released on 2014-07-29 with total page 494 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 Reliability Engineering Technology of Digital Diagnosis and Treatment Equipment written by Xiuqing Li and published by Springer Nature. This book was released on with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt:
