Automating Adverse Event Reporting and Safety Surveillance

Real-time algorithmic ingestion of device malfunction telemetries to dispatch compliant MedWatch and EUDAMED regulatory submissions.

Deterministic Malfunction Classification

Not every telemetry dropout is an adverse event. HealthVigilance applies clinical heuristics to distinguish network transient disconnections from actual sensor degradation.

EUDAMED and FDA Gateway Integration

By compiling FDA eMDR XML payloads and European Vigilance XML standards directly from the immutable telemetry ledger, audit overhead is reduced by over 80%.

Real-time event logging adhering to FDA 21 CFR Part 11 rules
Automatic severity scoring based on clinical vital thresholds
Encrypted audit trails establishing strict chain-of-custody

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