AEGIS operationalizes FDA's Predetermined Change Control Plan (PCCP) and EU AI Act Article 43(4) to govern iterative medical device AI model updates
Framework uses three modules: dataset assimilation/retraining, model monitoring, and conditional decision-making to maintain safety while enabling improvement
Introduces four-category deployment taxonomy (APPROVE, CONDITIONAL APPROVAL, CLINICAL REVIEW, REJECT) with independent Post-Market Surveillance alarm for detecting critical failures
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