The future ofMedical Intelligence
Three AI specialists: Clinical Safety, Operations, and Regulatory analyzing your medical devices continuously, delivering actionable intelligence when every decision matters.
Comprehensive Medical Device Intelligence
Three powerful services working together to ensure device safety and compliance
FDA Filing Analysis
Submit 510(k) and other FDA documents for comprehensive AI-powered evaluation and approval likelihood assessment.
Device Operations
Upload performance logs, maintenance records, and operational data for efficiency optimization recommendations.
Post-Market Surveillance
Real-time monitoring of multiple medical devices with automated compliance alerts and FDA notification triggers.
Three Specialized AI Agents
Working in consensus to provide balanced, comprehensive analysis
Clinical Agent
Patient Safety Focus
Analyzes clinical trial data, adverse events, and patient safety protocols.
Operations Agent
Efficiency Focus
Evaluates device performance, maintenance costs, and resource utilization.
Regulatory Agent
Compliance Focus
Ensures FDA compliance, reviews documentation, and predicts approval likelihood.
Intelligent Consensus Algorithm
Our proprietary consensus algorithm weighs input from all three agents, prioritizing patient safety while balancing operational efficiency and regulatory compliance. Each analysis provides weighted scores and actionable recommendations.
How It Works
From submission to insights in minutes, not months
Upload Documents
Submit FDA filings, device logs, or monitoring data
AI Analysis
Three specialized agents evaluate your submission
Consensus Generation
Weighted scoring produces actionable recommendations
Actionable Insights
Receive FDA approval likelihood and improvement steps
FDA Submissions
Premarket Approval
Medical Device Reports
Ready to transform your medical device development process?