AEGIS: An Operational Infrastructure for Post-Market Governance of Adaptive Medical AI Under US and EU Regulations

ArXi:2603.22322v1 Announce Type: cross Machine learning systems deployed in medical devices require governance frameworks that ensure safety while enabling continuous improvement. Regulatory bodies including the FDA and European Union have To illustrate how AEGIS can be instantiated across heterogeneous clinical contexts, we provide two examples: sepsis prediction from electronic health records and brain tumor segmentation from medical imaging. Both cases use identical governance architecture, differing only in configuration.