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 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 readers with...

This work details 100 examples of how to design a user interface that guards against potentially harmful use errors. The examples cover myriad features concerning hardware, software, and documents with emphasis placed on medical devices. This analysis is timely considering the intense focus within multiple worldwide industries to increase the safety of products, tolls, machines and systems, including those used by professionals and laypersons. This intense focus arises from the revelation that preventable error is among the leading causes of death, in the same magnitude of heart disease...