displayName
Medical Device Validation
workflowKind
governance
triggerType
event-driven
typicalCadence
per-release
complexity
cross-team
description
Validates medical device software per IEC 62304 and FDA 21 CFR Part
820 -- verifying requirements traceability matrices, executing
protocol-driven IQ/OQ/PQ test suites, confirming cybersecurity
controls per FDA premarket guidance, validating SOUP (Software of
Unknown Provenance) risk assessments, and assembling the Design
History File (DHF) for regulatory submission. Excludes clinical
trial execution.