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.
Document identifier
AAMI TIR50:2014/(R)2017
Title
Post-market surveillance of use error management
AAMI Category
Maintenance, Design, and Electrical Safety, Human Factors
Publication date
2014-03-10
International Relationship
| Price |
200 vnd |
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