User Interface Requirements for Medical Devices PDF Download
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Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1000471845
Category : Business & Economics
Languages : en
Pages : 235
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Book Description
This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths. The book presents the strong connection between user interface requirements and risk management for medical devices and instructs readers how to develop specific requirements that are sufficiently comprehensive and detailed to produce good results – a user-friendly product that is likely to be used correctly. The book’s tutorial content is complemented by many real-world examples of user interface requirements, including ones pertaining to an inhaler, automated external defibrillator, medical robot, and mobile app that a patient might use to manage her diabetes. The book is intended for people representing a variety of product development disciplines who have responsibility for producing safe, effective, usable, and satisfying medical devices, including those who are studying or working in human factors engineering, psychology, mechanical engineering, biomedical engineering, systems engineering, software programming, technical writing, industrial design, graphic design, and regulatory affairs.
Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1000471845
Category : Business & Economics
Languages : en
Pages : 235
Get Book Here
Book Description
This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths. The book presents the strong connection between user interface requirements and risk management for medical devices and instructs readers how to develop specific requirements that are sufficiently comprehensive and detailed to produce good results – a user-friendly product that is likely to be used correctly. The book’s tutorial content is complemented by many real-world examples of user interface requirements, including ones pertaining to an inhaler, automated external defibrillator, medical robot, and mobile app that a patient might use to manage her diabetes. The book is intended for people representing a variety of product development disciplines who have responsibility for producing safe, effective, usable, and satisfying medical devices, including those who are studying or working in human factors engineering, psychology, mechanical engineering, biomedical engineering, systems engineering, software programming, technical writing, industrial design, graphic design, and regulatory affairs.
Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 1040063756
Category : Medical
Languages : en
Pages : 285
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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 o
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. .
Author: Matthew Bret Weinger
Publisher: CRC Press
ISBN: 1420063510
Category : Technology & Engineering
Languages : en
Pages : 822
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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 E. Wiklund
Publisher: CRC Press
ISBN: 1040295363
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: Michael E. Wiklund, P.E.
Publisher: CRC Press
ISBN: 1466595892
Category : Medical
Languages : en
Pages : 472
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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: Jay Kalra and Nancy Lightner
Publisher: AHFE International
ISBN: 1958651559
Category : Technology & Engineering
Languages : en
Pages : 333
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Book Description
Proceedings of the 14th International Conference on Applied Human Factors and Ergonomics (AHFE 2023), July 20–24, 2023, San Francisco, USA
Author: Michael E. Wiklund
Publisher:
ISBN: 9781570206894
Category : Human engineering
Languages : en
Pages : 218
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Book Description
Author: Claudio Becchetti
Publisher: John Wiley & Sons
ISBN: 1118652460
Category : Science
Languages : en
Pages : 600
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Book Description
This book explains all of the stages involved in developingmedical devices; from concept to medical approval including systemengineering, bioinstrumentation design, signal processing,electronics, software and ICT with Cloud and e-Healthdevelopment. Medical Instrument Design and Development offers a comprehensivetheoretical background with extensive use of diagrams, graphics andtables (around 400 throughout the book). The book explains how thetheory is translated into industrial medical products using amarket-sold Electrocardiograph disclosed in its design by the GammaCardio Soft manufacturer. The sequence of the chapters reflects the product developmentlifecycle. Each chapter is focused on a specific University courseand is divided into two sections: theory and implementation. Thetheory sections explain the main concepts and principles whichremain valid across technological evolutions of medicalinstrumentation. The Implementation sections show how the theory istranslated into a medical product. The Electrocardiograph(ECG or EKG) is used as an example as it is a suitable device toexplore to fully understand medical instrumentation since it issufficiently simple but encompasses all the main areas involved indeveloping medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing,information theory, electronics, software, firmware, telemedicine,e-Health and medical device certification Explains how to use theory to implement a market product (usingECG as an example) Examines the design and applications of main medicalinstruments Details the additional know-how required for productimplementation: business context, system design, projectmanagement, intellectual property rights, product life cycle,etc. Includes an accompanying website with the design of thecertified ECG product (ahref="http://www.gammacardiosoft.it/book"www.gammacardiosoft.it/book/a) Discloses the details of a marketed ECG Product (from GammaCardio Soft) compliant with the ANSI standard AAMI EC 11under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses(upper-level undergraduate and graduate students) and for engineersinterested in medical instrumentation/device design with acomprehensive and interdisciplinary system perspective.
Author: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Category : Medical
Languages : en
Pages : 445
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Book Description
HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
