Smarteeva MDREngine

MDREngine: Global Safety Intelligence for Medical Device Management

MDREngine centralizes adverse events, device registrations, recall letters, and safety data from FDA MAUDE and global sources into a single, searchable data lake. AI-powered analytics and natural language search turn 2.6M+ raw safety records into actionable intelligence. Set alerts for specific devices, competitors, or event patterns. Compare your device’s performance against industry benchmarks.

MDREngine integrates directly with Smarteeva’s complaint management platform. Cross-reference your internal complaint data against industry patterns in real time, inside the same system where you manage complaints.

What You Will Learn

How customized precision search works across 2.6M+ records. How real-time monitoring provides continuous updates from FDA and global sources. How AI-powered analytics surface trends, anomalies, and competitive intelligence. How the public API enables integration with your existing systems and dashboards. How MDREngine supports signal detection validation, competitive surveillance, and regulatory submission benchmarking.

Data Sources

FDA MAUDE (Medical Device Adverse Event Reports). FDA device registrations and listings. FDA recall notifications and enforcement actions. Global vigilance data. All records cleaned, correlated, and linked for comprehensive cross-referencing. Continuously updated as new data becomes available.

‍