Usability Engineering File

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Usability Engineering

Written by the author of the best-selling HyperText & HyperMedia, this book is an excellent guide to the methods of usability engineering. The book provides the tools needed to avoid usability surprises and improve product quality. Step-by-step information on which method to use at various stages during the development lifecycle are included, along with detailed information on how to run a usability test and the unique issues relating to international usability.* Emphasizes cost-effective methods that developers can implement immediately* Instructs readers about which methods to use when, throughout the development lifecycle, which ultimately helps in cost-benefit analysis. * Shows readers how to avoid the four most frequently listed reasons for delay in software projects.* Includes detailed information on how to run a usability test.* Covers unique issues of international usability.* Features an extensive bibliography allowing readers to find additional information.* Written by an internationally renowned expert in the field and the author of the best-selling HyperText & HyperMedia.
Usability Testing of Medical Devices

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
The ASQ Certified Medical Device Auditor Handbook

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques