[
{
"control_id": "A.5.1",
"control_name": "Policies for information security",
"regulation": "IVDR",
"articles": ["10", "23"],
"coverage": "full",
"notes": "Quality management system and cybersecurity requirements"
},
{
"control_id": "A.5.8",
"control_name": "Information security in project management",
"regulation": "IVDR",
"articles": ["10", "56"],
"coverage": "full",
"notes": "Security in IVD device design and development"
},
{
"control_id": "A.5.31",
"control_name": "Legal, statutory, regulatory and contractual requirements",
"regulation": "IVDR",
"articles": ["1", "2"],
"coverage": "full",
"notes": "Regulatory framework for in vitro diagnostic devices"
},
{
"control_id": "A.5.33",
"control_name": "Protection of records",
"regulation": "IVDR",
"articles": ["10", "24"],
"coverage": "full",
"notes": "Technical documentation and UDI-DI requirements"
},
{
"control_id": "A.6.8",
"control_name": "Information security event reporting",
"regulation": "IVDR",
"articles": ["82", "83", "84"],
"coverage": "full",
"notes": "Vigilance reporting for serious incidents"
},
{
"control_id": "A.8.9",
"control_name": "Configuration management",
"regulation": "IVDR",
"articles": ["10"],
"coverage": "full",
"notes": "Device configuration and software version control"
},
{
"control_id": "A.8.24",
"control_name": "Use of cryptography",
"regulation": "IVDR",
"articles": ["10"],
"coverage": "partial",
"notes": "Security measures for connected IVD devices"
},
{
"control_id": "A.8.28",
"control_name": "Secure coding",
"regulation": "IVDR",
"articles": ["10"],
"coverage": "full",
"notes": "Software requirements in general safety and performance"
}
]
