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AAMI TIR50:2014/(R)2017

Post-market surveillance of use error management
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AAMI TIR50:2014/(R)2017

Post-market surveillance of use error management

PUBLISH DATE 2017
AAMI TIR50:2014/(R)2017
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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR50
Publication Date Jan. 1, 2017
Language en - English
Page Count 46
Revision Level
Supercedes
Committee
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