[
{
"control_id": "GV.OC-01",
"control_name": "Organizational context",
"regulation": "IVDR",
"articles": ["1", "2"],
"coverage": "full",
"notes": "In vitro diagnostic device regulatory context"
},
{
"control_id": "GV.RM-01",
"control_name": "Risk management objectives",
"regulation": "IVDR",
"articles": ["10", "14"],
"coverage": "full",
"notes": "Risk management for IVD devices"
},
{
"control_id": "GV.RR-01",
"control_name": "Organizational roles and responsibilities",
"regulation": "IVDR",
"articles": ["10", "11", "15"],
"coverage": "full",
"notes": "Manufacturer and authorized representative duties"
},
{
"control_id": "GV.SC-01",
"control_name": "Supply chain risk management program",
"regulation": "IVDR",
"articles": ["10", "22"],
"coverage": "full",
"notes": "Supply chain controls for IVD devices"
},
{
"control_id": "ID.AM-01",
"control_name": "Inventories of assets",
"regulation": "IVDR",
"articles": ["24", "25", "26"],
"coverage": "full",
"notes": "UDI system and device identification"
},
{
"control_id": "PR.DS-01",
"control_name": "Data-at-rest is protected",
"regulation": "IVDR",
"articles": ["100", "101"],
"coverage": "partial",
"notes": "EUDAMED database security"
},
{
"control_id": "RS.CO-03",
"control_name": "Information is shared with designated external parties",
"regulation": "IVDR",
"articles": ["82", "83", "84"],
"coverage": "full",
"notes": "Vigilance reporting and incident notification"
},
{
"control_id": "RS.MA-01",
"control_name": "Incident response plan is executed",
"regulation": "IVDR",
"articles": ["82", "83"],
"coverage": "full",
"notes": "Serious incident reporting procedures"
}
]
