| Health / Medical Topics |
Device Use Testing Evaluation Method
Any testing performed that simulates real use situations experienced by users. (Food and Drug Administration)
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Terminology used in Individual Case Safety Reports to specify a type of device usage, section H8 of FDA MedWatch Form.
An unused device that has been returned in packaging that remains intact.
The device software contained code that could never be executed under any circumstance.
Testing of individual hardware or software components or groups of related units.
The device software did not correctly address abnormal execution of the code.
A situation when a procedure or operation involving use of medical device is performed without required level of care, supervision, or constant…
