usability testing of medical devices second edition

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Usability Testing Of Medical Devices

Author : Michael E. Wiklund P.E.
ISBN : 9781466595897
Genre : Medical
File Size : 77. 35 MB
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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

International Encyclopedia Of Ergonomics And Human Factors Second Edition 3 Volume Set

Author : Waldemar Karwowski
ISBN : 041530430X
Genre : Technology & Engineering
File Size : 50. 60 MB
Format : PDF, ePub
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The previous edition of the International Encyclopedia of Ergonomics and Human Factors made history as the first unified source of reliable information drawn from many realms of science and technology and created specifically with ergonomics professionals in mind. It was also a winner of the Best Reference Award 2002 from the Engineering Libraries Division, American Society of Engineering Education, USA, and the Outstanding Academic Title 2002 from Choice Magazine. Not content to rest on his laurels, human factors and ergonomics expert Professor Waldemar Karwowski has overhauled his standard-setting resource, incorporating coverage of tried and true methods, fundamental principles, and major paradigm shifts in philosophy, thought, and design. Demonstrating the truly interdisciplinary nature of this field, these changes make the second edition even more comprehensive, more informative, more, in a word, encyclopedic. Keeping the format popularized by the first edition, the new edition has been completely revised and updated. Divided into 13 sections and organized alphabetically within each section, the entries provide a clear and simple outline of the topics as well as precise and practical information. The book reviews applications, tools, and innovative concepts related to ergonomic research. Technical terms are defined (where possible) within entries as well as in a glossary. Students and professionals will find this format invaluable, whether they have ergonomics, engineering, computing, or psychology backgrounds. Experts and researchers will also find it an excellent source of information on areas beyond the range of their direct interests.

Development Of Fda Regulated Medical Products Second Edition

Author : Elaine Whitmore
ISBN : 9780873898331
Genre : Business & Economics
File Size : 68. 35 MB
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Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates.

Design Of Biomedical Devices And Systems Second Edition

Author : Paul H. King
ISBN : 9781439878071
Genre : Medical
File Size : 72. 26 MB
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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.

Handbook Of Human Factors And Ergonomics In Health Care And Patient Safety Second Edition

Author : Pascale Carayon
ISBN : 9781439830345
Genre : Technology & Engineering
File Size : 80. 32 MB
Format : PDF, ePub
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The first edition of Handbook of Human Factors and Ergonomics in Health Care and Patient Safety took the medical and ergonomics communities by storm with in-depth coverage of human factors and ergonomics research, concepts, theories, models, methods, and interventions and how they can be applied in health care. Other books focus on particular human factors and ergonomics issues such as human error or design of medical devices or a specific application such as emergency medicine. This book draws on both areas to provide a compendium of human factors and ergonomics issues relevant to health care and patient safety. The second edition takes a more practical approach with coverage of methods, interventions, and applications and a greater range of domains such as medication safety, surgery, anesthesia, and infection prevention. New topics include: work schedules error recovery telemedicine workflow analysis simulation health information technology development and design patient safety management Reflecting developments and advances in the five years since the first edition, the book explores medical technology and telemedicine and puts a special emphasis on the contributions of human factors and ergonomics to the improvement of patient safety and quality of care. In order to take patient safety to the next level, collaboration between human factors professionals and health care providers must occur. This book brings both groups closer to achieving that goal.

Handbook Of Medical Device Design

Author : Richard C. Fries
ISBN : 0824703995
Genre : Medical
File Size : 44. 61 MB
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The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include

The Biomedical Quality Auditor Handbook Second Edition

Author : ASQ Biomedical Division
ISBN : 9780873898362
Genre : Business & Economics
File Size : 39. 16 MB
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This handbook serves as a reference source for the application of quality auditing principles to the biomedical industry, including coverage specifically pertaining to medical devices. The book focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing, and includes information on related regulations, directives, standards, and guidance. The book covers a wide range of subjects that have specific interpretations unique to the biomedical industry. In addition to being a peerless reference for ASQ's Biomedical Auditor certification (CBA), this book is a valuable reference for biomedical professionals who want to execute better audits for medical devices and gain basic knowledge of biomedical technical areas and regulatory requirements.

Design Controls For The Medical Device Industry Second Edition

Author : Marie B. Teixeira
ISBN : 9781466503540
Genre : Medical
File Size : 20. 83 MB
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The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.

Encyclopedia Of Medical Devices And Instrumentation Echocardiography And Doppler Echocardiography Human Spine Biomechanics Of

Author : John G. Webster
ISBN : 0470040688
Genre : Science
File Size : 79. 84 MB
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This set is an alphabetically organized compilation of about 300 articles that describe critical aspects of medical devices and instrumentation. The articles emphasize the contributions of engineering, physics, and computers to each of the general areas of anesthesiology, biomaterials, burns, cardiology, clinical chemistry, clinical engineering, communicative disorders, computers in medicine, critical care medicine, dermatology, dentistry, ear, nose, and throat, emergency medicine, endocrinology, gastroenterology, genetics, geriatrics, gynecology, hematology, heptology, internal medicine, medical physics, microbiology, nephrology, neurology, nutrition, obstetrics, oncology, ophthalmology, orthopedics, pain, pediatrics, peripheral vascular disease, pharmacology, physical therapy, psychiatry, pulmonary medicine, radiology, rehabilitation, surgery, tissue engineering, transducers, and urology.

Reliable Design Of Medical Devices

Author : Richard C. Fries
ISBN : 1420001019
Genre : Medical
File Size : 53. 9 MB
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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.

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