{
  "id": "workflow:medical-device-validation",
  "_kind": "Workflow",
  "_file": "workflows/workflows/workflows-biomedical.yaml",
  "_cluster": "workflows",
  "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\n820 -- verifying requirements traceability matrices, executing\nprotocol-driven IQ/OQ/PQ test suites, confirming cybersecurity\ncontrols per FDA premarket guidance, validating SOUP (Software of\nUnknown Provenance) risk assessments, and assembling the Design\nHistory File (DHF) for regulatory submission. Excludes clinical\ntrial execution.\n"
  },
  "outgoingEdges": [
    {
      "from": "workflow:medical-device-validation",
      "to": "role:principal-engineer",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "role:test-writer",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "role:security-reviewer",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "skill-area:integration-testing",
      "kind": "requires_skill_area",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "skill-area:firmware-development",
      "kind": "requires_skill_area",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "domain:biomedical-engineering",
      "kind": "applies_to_domain",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "domain:embedded-systems",
      "kind": "applies_to_domain",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "responsibility:release-coordination",
      "kind": "triggers_responsibility",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "responsibility:security-review",
      "kind": "triggers_responsibility",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "org-unit:quality-engineering",
      "kind": "performed_by_org_unit",
      "attributes": {}
    },
    {
      "from": "workflow:medical-device-validation",
      "to": "org-unit:engineering",
      "kind": "performed_by_org_unit",
      "attributes": {}
    }
  ],
  "incomingEdges": []
}