II.
Workflow overview
Reference · liveworkflow:medical-device-validation
Medical Device Validation overview
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.
Attributes
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.
Outgoing edges
applies_to_domain2
- domain:biomedical-engineering·DomainBiomedical Engineering
- domain:embedded-systems·DomainEmbedded Systems
involves_role3
- role:principal-engineer·RolePrincipal Engineer
- role:test-writer·RoleTest Writer
- role:security-reviewer·RoleSecurity Reviewer
performed_by_org_unit2
- org-unit:quality-engineering·OrgUnitQuality Engineering
- org-unit:engineering·OrgUnitEngineering
requires_skill_area2
- skill-area:integration-testing·SkillAreaIntegration Testing
- skill-area:firmware-development·SkillAreaFirmware Development
triggers_responsibility2
- responsibility:release-coordination·Responsibility
- responsibility:security-review·ResponsibilitySecurity review
Incoming edges
None.