{
  "id": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
  "_kind": "LibraryProcess",
  "_file": "generated-library/processes.yaml",
  "_cluster": "generated-library",
  "attributes": {
    "displayName": "software-lifecycle-iec62304",
    "description": "Medical Device Software Development Lifecycle per IEC 62304 - Implement software development\nlifecycle including planning, requirements, design, implementation, verification, and maintenance.",
    "libraryPath": "library/specializations/domains/science/biomedical-engineering/software-lifecycle-iec62304.js",
    "specialization": "biomedical-engineering",
    "references": [
      "- IEC 62304:2006/AMD1:2015 Medical device software - Software life cycle processes\n- FDA Guidance on General Principles of Software Validation\n- IEC 82304-1 Health software - General requirements for product safety"
    ],
    "example": "const result = await orchestrate('specializations/domains/science/biomedical-engineering/software-lifecycle-iec62304', {\n  softwareName: 'Patient Monitoring Software',\n  safetyClass: 'Class B',\n  intendedUse: 'Real-time vital signs monitoring and alarming',\n  developmentModel: 'Agile-with-gates'\n});",
    "usesAgents": [
      "general-purpose"
    ]
  },
  "outgoingEdges": [
    {
      "from": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
      "to": "skill-area:data-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
      "to": "skill-area:sensor-fusion",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
      "to": "skill-area:statistical-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
      "to": "domain:biomedical-engineering",
      "kind": "lib_applies_to_domain",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
      "to": "role:biomedical-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
      "to": "role:research-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
      "to": "workflow:experiment-design",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
      "to": "workflow:peer-review-cycle",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--software-lifecycle-iec62304",
      "to": "specialization:biomedical-engineering",
      "kind": "lib_belongs_to_specialization",
      "attributes": {
        "weight": 0.9
      }
    }
  ],
  "incomingEdges": []
}