High Percentage of Medical Device interface performance Issues

High Percentage of Medical Device interface performance Issues (kri)
Type of indicator Performance
Risk Category data collection procedures
Golden KRI NO
Therapeutic Area Medical Devices
IF Risk-Event the interface between the Medical Device and any other system does not work
DUE TO Risk Causes insufficient testing of the interface
THEN Risk Impact MAY RESULT out of sync data
Risk Indicator High Percentage of Medical Device interface performance Issues
Metric Percent of the interface malfunction
Unit %
What level should be measured Study, Country, Site
Suggested Thresholds - High ≥5 %
Suggested Thresholds - Medium ≥3 %
Associated Metric 1 Number of enrolled Subjects
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