[
{
"control_id": "A.5.1",
"control_name": "Policies for information security",
"regulation": "MDR",
"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": "MDR",
"articles": ["10", "61"],
"coverage": "full",
"notes": "Security considerations in device design and development"
},
{
"control_id": "A.5.23",
"control_name": "Information security for use of cloud services",
"regulation": "MDR",
"articles": ["10"],
"coverage": "partial",
"notes": "Connected device security requirements"
},
{
"control_id": "A.5.31",
"control_name": "Legal, statutory, regulatory and contractual requirements",
"regulation": "MDR",
"articles": ["1", "2", "3"],
"coverage": "full",
"notes": "Comprehensive regulatory framework for medical devices"
},
{
"control_id": "A.5.33",
"control_name": "Protection of records",
"regulation": "MDR",
"articles": ["10", "87"],
"coverage": "full",
"notes": "Technical documentation and UDI requirements"
},
{
"control_id": "A.6.8",
"control_name": "Information security event reporting",
"regulation": "MDR",
"articles": ["87", "88", "89"],
"coverage": "full",
"notes": "Vigilance reporting for serious incidents"
},
{
"control_id": "A.8.9",
"control_name": "Configuration management",
"regulation": "MDR",
"articles": ["10"],
"coverage": "full",
"notes": "Device configuration and version control requirements"
},
{
"control_id": "A.8.24",
"control_name": "Use of cryptography",
"regulation": "MDR",
"articles": ["10"],
"coverage": "partial",
"notes": "Security measures for connected medical devices"
},
{
"control_id": "A.8.28",
"control_name": "Secure coding",
"regulation": "MDR",
"articles": ["10"],
"coverage": "full",
"notes": "Software safety and security requirements in Annex I"
},
{
"control_id": "A.8.31",
"control_name": "Separation of development, test and production environments",
"regulation": "MDR",
"articles": ["10"],
"coverage": "partial",
"notes": "Quality management includes development environment controls"
}
]
