Usability Testing of Medical Devices Pdf The publication also discusses regulations and industry standards that inspire many medical device makers to run usability evaluations. Since publication of this first variant, the FDA and other regulatory teams have altered their expectations and regulations concerning the way medical device manufacturers must strategy usability testing. Reflecting these modifications, this Second Edition provides updated advice to viewers with an interest or direct part in conducting a usability evaluation of a medical apparatus or system.
Crucial updates include the 2011 FDA advice on human factors engineering, demands set forth from the next edition of IEC 60601 and closely connected IEC 62366-1:2015, linking usability evaluation tasks to hazard analysis results, and assessing root causes of usage errors which happen during usability evaluations. Written by experienced human factors experts, Usability Testing of Medical Devices, Second Edition is an informative, functional, and up-to-date manual for conducting usability evaluations of medical devices. The publication helps to ensure a smooth and painless growth process?and hence, secure and effective medical devices.