How engineering teams can build automated telemetry pipelines to monitor medical AI performance and report adverse events directly to regulatory bodies.
Regulatory clearance is only the beginning of a medical device's lifecycle. FDA 21 CFR 822 and EU MDR Article 83 mandate active, systematic post-market surveillance to detect unexpected clinical complications, population drift, and real-world performance degradation.
We explain how AgenticSaMD continuously aggregates real-world clinical outcome data: when a diagnostic discrepancy or adverse patient event occurs, automated pipelines package the complete diagnostic trace, model weights version, and clinical context into standardized electronic Medical Device Reporting (eMDR) payloads.
Statistical methodologies (CUSUM charts, Population Stability Index) to detect when changes in hospital imaging equipment, lab reagents, or patient demographics degrade model accuracy before patient safety is compromised.