{
  "id": "lib-process:biomedical-engineering--design-control-process",
  "_kind": "LibraryProcess",
  "_file": "generated-library/processes.yaml",
  "_cluster": "generated-library",
  "attributes": {
    "displayName": "design-control-process",
    "description": "Design Control Process Implementation per FDA 21 CFR 820.30 - Implement comprehensive design\ncontrol processes including user needs capture, design inputs/outputs, verification, validation,\ndesign transfer, and design history file management for medical device development.",
    "libraryPath": "library/specializations/domains/science/biomedical-engineering/design-control-process.js",
    "specialization": "biomedical-engineering",
    "references": [
      "- FDA 21 CFR 820.30 Design Controls: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30\n- FDA Design Control Guidance for Medical Device Manufacturers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers\n- ISO 13485:2016 Medical Devices Quality Management Systems"
    ],
    "example": "const result = await orchestrate('specializations/domains/science/biomedical-engineering/design-control-process', {\n  deviceName: 'Smart Insulin Pump',\n  deviceClass: 'Class II',\n  intendedUse: 'Continuous subcutaneous insulin infusion for diabetes management',\n  userNeeds: ['Accurate dosing', 'Portable design', 'Easy to use interface'],\n  regulatoryPathway: '510(k)'\n});",
    "usesAgents": [
      "general-purpose"
    ]
  },
  "outgoingEdges": [
    {
      "from": "lib-process:biomedical-engineering--design-control-process",
      "to": "skill-area:data-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--design-control-process",
      "to": "skill-area:sensor-fusion",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--design-control-process",
      "to": "skill-area:statistical-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--design-control-process",
      "to": "domain:biomedical-engineering",
      "kind": "lib_applies_to_domain",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--design-control-process",
      "to": "role:biomedical-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--design-control-process",
      "to": "role:research-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--design-control-process",
      "to": "workflow:experiment-design",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--design-control-process",
      "to": "workflow:peer-review-cycle",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--design-control-process",
      "to": "specialization:biomedical-engineering",
      "kind": "lib_belongs_to_specialization",
      "attributes": {
        "weight": 0.9
      }
    }
  ],
  "incomingEdges": []
}