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v1.0.4-LATEST

ISO 13485

Architectural Definition

The international standard for a quality management system specific to the medical devices industry.

Schema Preview

application/json
{
  "entity": "iso-13485",
  "domain": "pharmacy",
  "metadata": {
    "displayName": "ISO 13485",
    "status": "DRAFT",
    "version": "1.0.4",
    "isStandardized": false
  }
}
Standard
ISO-8601
Data Type
String/Obj
Steward
Arch Council
Verified
Feb 2026