Usability Testing of Medical Devices PDF Download
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Author: Michael E. Wiklund P.E.
Publisher: CRC Press
ISBN: 1466595892
Category : Medical
Languages : en
Pages : 477
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Book Description
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
Author: Michael E. Wiklund P.E.
Publisher: CRC Press
ISBN: 1466595892
Category : Medical
Languages : en
Pages : 477
Get Book
Book Description
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
Author: Michael E. Wiklund, P.E.
Publisher: CRC Press
ISBN: 9781466595880
Category : Medical
Languages : en
Pages : 0
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Book Description
Since the publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this second edition provides updated guidance to medical device manufacturers and other interested readers. Key updates include new requirements, detailed instructions for linking usability test tasks to risk analysis results, and methods for analyzing root causes of use errors that occur during usability tests. The book’s authors are well-known thought leaders in the medical device industry.
Author: Michael Wiklung
Publisher:
ISBN: 9780429169908
Category : Medical instruments and apparatus
Languages : en
Pages :
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Book Description
Author: Matthew Bret Weinger
Publisher: CRC Press
ISBN: 1420063510
Category : Technology & Engineering
Languages : en
Pages : 844
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Book Description
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
Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1498705804
Category : Medical
Languages : en
Pages : 267
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Book Description
Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error-a mistake-that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors
Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128161647
Category : Science
Languages : en
Pages : 371
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Book Description
Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) Explains technology development and the application of human factors throughout the development process Covers FDA and MHRA regulations Includes case examples with each method
Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 9780935184693
Category : Technology & Engineering
Languages : en
Pages : 402
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Book Description
The key to profitability and success in both the medical device and the equipment markets often relates to how easy your products are to use. User acceptance and preference frequently is dependent upon ergonomic design. Medical Device and Equipment Design helps you enhance your product design, maximize user acceptance, and minimize potential problems in the marketplace. It provides practical guidance on how to plan and incorporate ergonomic design principles into medical devices and equipment so users intuitively feel comfortable with the product. Design engineers, usability and reliability engineers, software programmers, documentation specialists, product managers, quality engineers, and market/product managers will find this text invaluable in getting usability built into products from the very beginning.
Author: Carol M. Barnum
Publisher: Morgan Kaufmann
ISBN: 0128169435
Category : Computers
Languages : en
Pages : 481
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Book Description
Usability Testing Essentials presents a practical, step-by-step approach to learning the entire process of planning and conducting a usability test. It explains how to analyze and apply the results and what to do when confronted with budgetary and time restrictions. This is the ideal book for anyone involved in usability or user-centered design—from students to seasoned professionals.Filled with new examples and case studies, Usability Testing Essentials, Second Edition is completely updated to reflect the latest approaches, tools and techniques needed to begin usability testing or to advance in this area. Provides a comprehensive, step-by-step guide to usability testing, a crucial part of every product’s development Discusses important usability issues such as international testing, persona creation, remote testing, and accessibility Presents new examples covering mobile devices and apps, websites, web applications, software, and more Includes strategies for using tools for moderated and unmoderated testing, expanded content on task analysis, and on analyzing and reporting results
Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 1420038087
Category : Medical
Languages : en
Pages : 376
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Book Description
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 of alternative approaches to the subject. Wiklund and Wilcox explore how to make medical devices safe and effective by involving users in the design process. They discuss specific design and evaluation methods and tools, present case studies of user-friendly medical technologies and corporate human factors programs, and supply related resources for medical design professionals. The book conveys an in-depth understanding of the user-centered design process, covers design methods for FDA compliance, and offers guidance on performing a variety of hands-on user research, user interface design, and user interface evaluation. The authors make a compelling case for treating the user's needs and preferences as a top design priority, rather than an afterthought. They demonstrate that high-quality customer interactions with systems and products leads to effective medical diagnosis and treatment, increases the physical and mental well being of patients and caregivers, and leads to commercial success in a crowded marketplace.
Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1351579150
Category : Business & Economics
Languages : en
Pages : 588
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Book Description
How do you prevent a critical care nurse from accidentally delivering a morphine overdose to an ill patient? Or ensure that people don't insert their arm into a hydraulic mulcher? And what about enabling trapped airline passengers to escape safely in an emergency? Product designers and engineers face myriad such questions every day. Failure to answer them correctly can result in product designs that lead to injury or even death due to use error. Historically, designers and engineers have searched for answers by sifting through complicated safety standards or obscure industry guidance documents. Designing for Safe Use is the first comprehensive source of safety-focused design principles for product developers working in any industry. Inside you’ll find 100 principles that help ensure safe interactions with products as varied as baby strollers, stepladders, chainsaws, automobiles, apps, medication packaging, and even airliners. You’ll discover how protective features such as blade guards, roll bars, confirmation screens, antimicrobial coatings, and functional groupings can protect against a wide range of dangerous hazards, including sharp edges that can lacerate, top-heavy items that can roll over and crush, fumes that can poison, and small parts that can pose a choking hazard. Special book features include: Concise, illustrated descriptions of design principles Sample product designs that illustrate the book’s guidelines and exemplify best practices Literature references for readers interested in learning more about specific hazards and protective measures Statistics on the number of injuries that have arisen in the past due to causes that might be eliminated by applying the principles in the book Despite its serious subject matter, the book’s friendly tone, surprising anecdotes, bold visuals, and occasional attempts at dry humor will keep you interested in the art and science of making products safer. Whether you read the book cover-to-cover or jump around, the book’s relatable and practical approach will help you learn a lot about making products safe. Designing for Safe Use is a primer that will spark in readers a strong appreciation for the need to design safety into products. This reference is for designers, engineers, and students who seek a broad knowledge of safe design solutions. .
