This document will address the issue of use error detection for medical devices from clinical, manufacturer, and regulatory perspective regarding human factors assessment. The goal is to provide guidance on how clinicians and manufacturers can best collect and leverage post-market use error data to improve product safety and usability.
AAMI TIR50:2014/(R)2017
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Post-market surveillance of use error management
Association for the Advancement of Medical Instrumentation , 03/10/2014
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