Post-Market Surveillance
Real-time device monitoring with automated compliance alerts and FDA notifications
Overview
The Post-Market Surveillance module provides real-time monitoring of multiple medical devices, tracking uptime, maintenance status, and compliance scores. Our AI continuously analyzes device performance and automatically identifies situations requiring FDA notification under Medical Device Reporting (MDR) regulations.
Key Feature: Automated FDA MDR alerts help ensure timely reporting of adverse events, malfunctions, and serious injuries as required by 21 CFR Part 803.
Device Grid Interface
Status Indicators
Real-Time Metrics
Uptime Score
Percentage of operational time vs total time
Maintenance Score
Preventive maintenance compliance rate
Compliance Score
Regulatory compliance and safety metrics
FDA Notification System
Automatic MDR Detection
Deffai automatically identifies events requiring FDA notification:
- •Deaths: Any device-related fatality
- •Serious Injuries: Life-threatening, permanent impairment, or requiring intervention
- •Malfunctions: Failures that could cause death or serious injury if recurred
Notification Timeline
AI-Powered Recommendations
When you select a device from the monitoring grid, our AI agents analyze its data and provide:
Predictive Insights
- • Component failure predictions
- • Maintenance scheduling optimization
- • Performance degradation trends
- • Calibration drift warnings
Corrective Actions
- • Immediate safety measures
- • Root cause investigations
- • Preventive action plans
- • Documentation requirements
Best Practices
Daily Monitoring
Review the device grid daily, focusing on devices with warning or critical status. Address issues promptly to prevent escalation.
Document Actions
Keep detailed records of all corrective actions taken in response to alerts. This documentation is crucial for FDA audits and inspections.
Trend Analysis
Use the monitoring data to identify patterns across similar devices. This can reveal systemic issues requiring design changes or recalls.
Compliance Thresholds
Set up alerts for devices approaching compliance thresholds. Proactive intervention prevents regulatory violations.
Integration Capabilities
Device Connectivity
Connect devices via IoT protocols for real-time data streaming. Supports MQTT, HTTPS, and custom APIs.
CMMS Integration
Integrate with Computerized Maintenance Management Systems to automatically sync maintenance schedules and work orders.
Alert Routing
Configure alerts to route to appropriate personnel via email, SMS, or integration with incident management systems.
Experience Real-Time Monitoring
See how post-market surveillance works with our simulated device fleet.
Go to Device Monitoring