{
  "id": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
  "_kind": "LibraryProcess",
  "_file": "generated-library/processes.yaml",
  "_cluster": "generated-library",
  "attributes": {
    "displayName": "specializations/domains/science/biomedical-engineering/medical-device-tplc-workflow",
    "description": "Flagship medical-device total-product-lifecycle workflow: design-control intake ->\n  ISO 14971 risk management -> parallel design characterization (biological evaluation,\n  sterilization/sterile-barrier, human factors, IEC 62304 software) -> DESIGN FREEZE\n  (policy-gated) -> verification and validation over the frozen baseline -> clinical evaluation\n  with policy-gated first-in-human authorization -> Design History File sufficiency gate ->\n  policy-gated regulatory submission with bounded deficiency-response rounds -> post-market\n  surveillance with severity-routed CAPA, policy-gated field action and policy-gated vigilance\n  filing. Composes the 14 biomedical point processes BY NAME (never imported).",
    "libraryPath": "library/specializations/domains/science/biomedical-engineering/medical-device-tplc-workflow.js",
    "specialization": "biomedical-engineering",
    "example": "const result = await orchestrate('specializations/domains/science/biomedical-engineering/medical-device-tplc-workflow', {\n  deviceName: 'Acme Infusion Pump X1',\n  intendedUse: 'Continuous intravenous infusion of therapeutic fluids in acute-care settings',\n  deviceClass: 'Class II',\n  regulatoryPathway: '510k',\n  markets: ['US'],\n  hasSoftware: true,\n  predicateDevices: [{ name: 'Acme Infusion Pump X0', k510: 'K123456' }],\n  maxSubmissionRounds: 2\n});",
    "usesAgents": [
      "design-control-planner",
      "risk-management-engineer",
      "biocompatibility-engineer",
      "sterilization-validation-engineer",
      "human-factors-engineer",
      "medical-software-engineer",
      "configuration-manager",
      "vv-planner",
      "vv-engineer",
      "vv-reporter",
      "clinical-study-designer",
      "clinical-operations-lead",
      "clinical-evaluation-author",
      "dhf-assembler",
      "regulatory-dossier-author",
      "regulatory-submission-agent",
      "regulatory-deficiency-responder",
      "pms-lead",
      "signal-analyst",
      "capa-investigator",
      "field-action-coordinator",
      "vigilance-reporter"
    ]
  },
  "outgoingEdges": [
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "skill-area:risk-management",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "skill-area:verification-validation",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "skill-area:regulatory-affairs",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "skill-area:human-factors-engineering",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "topic:compliance-traceability",
      "kind": "lib_covers_topic",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "topic:medical-device-regulation",
      "kind": "lib_covers_topic",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "domain:biomedical-engineering",
      "kind": "lib_applies_to_domain",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "domain:healthcare",
      "kind": "lib_applies_to_domain",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "role:biomedical-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "role:regulatory-affairs-lead",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "role:quality-management-representative",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "role:design-assurance-lead",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "role:medical-director",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "workflow:product-lifecycle",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "workflow:release-management",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "specialization:biomedical-engineering",
      "kind": "lib_belongs_to_specialization",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "specialization:data-privacy-compliance",
      "kind": "lib_belongs_to_specialization",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--medical-device-tplc-workflow",
      "to": "lib-agent:biomedical-engineering--human-factors-engineer",
      "kind": "uses_agent",
      "attributes": {
        "weight": 0.8
      }
    }
  ],
  "incomingEdges": []
}