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Post-market surveillance of use error management
Published by | Publication Date | Number of Pages |
AAMI | 03/10/2014 | 46 |
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AAMI TIR50 – Post-market surveillance of use error management
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.
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