AEGIS: An Operational Infrastructure for Post-Market Governance of Adaptive Medical AI Under US and EU Regulations
AEGIS is an AI/ML governance framework designed to meet US FDA and EU AI Act regulations for adaptive medical devices. It operationalizes change control plans by using three modules: data assimilation, model monitoring, and conditional decision-making. The system uses a four-category deployment taxonomy plus an independent alarm signal to detect critical safety states where no safe model exists.