{
  "node_id": "medical-device-software-validation-iec62304-2026",
  "title": "Medical Device Software Validation & Lifecycle Processes - IEC 62304 (2026)",
  "domain": "Medical & Healthcare",
  "version": "1.0.0",
  "last_updated": "2026-05-20",
  "bluf": "IEC 62304 specifies lifecycle requirements for the development of medical software and software within medical devices. It mandates a risk-based software safety classification (Class A, B, C) which determines the required rigor for software architecture, detailed design, unit verification, integration testing, and system testing.",
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    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
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  "crosswalks": {
    "_available_keys": [
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    "_note": "Full crosswalk values included in vault response"
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  "primary_citations_count": 1
}