{
  "id": "workflow:biocompatibility-testing-cycle",
  "_kind": "Workflow",
  "_file": "workflows/workflows/workflows-thin-domains-fill.yaml",
  "_cluster": "workflows",
  "attributes": {
    "displayName": "Biocompatibility Testing Cycle",
    "workflowKind": "governance",
    "triggerType": "event-driven",
    "typicalCadence": "per-release",
    "complexity": "cross-team",
    "description": "Manages the biocompatibility testing lifecycle for medical devices\nper ISO 10993 -- selecting appropriate biological evaluation\nendpoints based on device contact type and duration, coordinating\ncytotoxicity, sensitization, and irritation testing with accredited\nlabs, reviewing extractable and leachable study protocols against\nmaterial composition data, tracking testing status across the\nbiological evaluation matrix, evaluating historical biocompatibility\ndata for predicate device equivalence claims, and compiling\nbiological evaluation reports for regulatory submission. Produces\nbiological evaluation plan, test status tracker, and BER (Biological\nEvaluation Report). Excludes device design changes.\n"
  },
  "outgoingEdges": [
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "role:principal-engineer",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "role:test-writer",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "role:planner",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "skill-area:integration-testing",
      "kind": "requires_skill_area",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "skill-area:data-quality",
      "kind": "requires_skill_area",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "domain:biomedical-engineering",
      "kind": "applies_to_domain",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "domain:healthcare",
      "kind": "applies_to_domain",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "responsibility:review-architecture-changes",
      "kind": "triggers_responsibility",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "responsibility:data-quality-monitoring",
      "kind": "triggers_responsibility",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "org-unit:quality-engineering",
      "kind": "performed_by_org_unit",
      "attributes": {}
    },
    {
      "from": "workflow:biocompatibility-testing-cycle",
      "to": "org-unit:research-engineering",
      "kind": "performed_by_org_unit",
      "attributes": {}
    }
  ],
  "incomingEdges": []
}