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AAMI TIR50:2014/(R)2017

Post-market surveillance of use error management

Summary

This document addresses 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. No annex

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2014
Confirmation Date 01/01/2017
Page Count 0
Themes Human factors
EAN ---
ISBN ---
Weight (in grams) ---
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