| Health / Medical Topics |
Device Software Validation Evaluation Method
Validating that a system or component during or at the end of the development process satisfies specified requirements (the process may include algorithm evaluation). (Food and Drug Administration)
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A device problem that results from the incorrect sequencing or activation of software modules.
Tests conducted to evaluate a software application at or beyond the limits of its specified requirements.
The device software failed to provide adequate authorization, access control, and accountability features.
The device software failed during operation as a result of a coding error.
The software requirements for the device are either incomplete, inadequate, or in conflict.
The device software failed because two or more processes compete with each other such that the program does not perform as…
