Signal Detection Engine
Continuously monitor MAUDE, vigilance databases, and literature for emerging safety signals with AI-classified severity scoring and automated trending analysis.
Post-Market Surveillance Intelligence
Detect safety signals across 1M+ MDR records with AI-powered surveillance, automated MAUDE analysis, and proactive CAPA intelligence.
Capabilities
Post-Market Surveillance Capabilities
Continuous monitoring and signal detection across global post-market data sources.
MAUDE Analysis Intelligence
Transform raw MDR data into actionable insights with automated event coding, duplicate detection, and causal analysis across device families and product codes.
CAPA Intelligence
Accelerate corrective and preventive action decisions with root cause analysis, effectiveness monitoring, and regulatory impact assessment across global markets.
PMS Report Automation
Generate periodic safety update reports, post-market surveillance plans, and trend reports with automated data aggregation and regulatory-ready formatting.
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