{
  "id": "lib-process:biomedical-engineering--risk-management-iso14971",
  "_kind": "LibraryProcess",
  "_file": "generated-library/processes.yaml",
  "_cluster": "generated-library",
  "attributes": {
    "displayName": "risk-management-iso14971",
    "description": "Medical Device Risk Management per ISO 14971 - Conduct comprehensive risk management\nthroughout the medical device lifecycle including hazard identification, risk estimation, risk evaluation,\nrisk control, and residual risk assessment.",
    "libraryPath": "library/specializations/domains/science/biomedical-engineering/risk-management-iso14971.js",
    "specialization": "biomedical-engineering",
    "references": [
      "- ISO 14971:2019 Medical devices - Application of risk management to medical devices\n- ISO/TR 24971:2020 Guidance on the application of ISO 14971\n- FDA Guidance on Risk Management: https://www.fda.gov/regulatory-information/search-fda-guidance-documents"
    ],
    "example": "const result = await orchestrate('specializations/domains/science/biomedical-engineering/risk-management-iso14971', {\n  deviceName: 'Cardiac Pacemaker',\n  intendedUse: 'Cardiac rhythm management for bradycardia patients',\n  deviceCategory: 'Active Implantable',\n  existingRiskData: null\n});",
    "usesAgents": [
      "general-purpose"
    ]
  },
  "outgoingEdges": [
    {
      "from": "lib-process:biomedical-engineering--risk-management-iso14971",
      "to": "skill-area:data-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--risk-management-iso14971",
      "to": "skill-area:sensor-fusion",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--risk-management-iso14971",
      "to": "skill-area:statistical-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--risk-management-iso14971",
      "to": "domain:biomedical-engineering",
      "kind": "lib_applies_to_domain",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--risk-management-iso14971",
      "to": "role:biomedical-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--risk-management-iso14971",
      "to": "role:research-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--risk-management-iso14971",
      "to": "workflow:experiment-design",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--risk-management-iso14971",
      "to": "workflow:peer-review-cycle",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--risk-management-iso14971",
      "to": "specialization:biomedical-engineering",
      "kind": "lib_belongs_to_specialization",
      "attributes": {
        "weight": 0.9
      }
    }
  ],
  "incomingEdges": []
}