AAMI TIR50:2014/(R)2017

Post-market surveillance of use error management

Association for the Advancement of Medical Instrumentation , 03/10/2014

Publisher: AAMI

File Format: PDF

$110.00$220.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 03/10/2014

Published:03/10/2014

Pages:46

ISBN(s):9781570205149

File Size:1 file , 740 KB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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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