Adverse Event Reporting

Report and track adverse events with workflows aligned to global regulatory requirements including EU MDR vigilance and FDA MDR reporting. Ensure timely submissions to authorities and maintain complete records of every reportable event.

See It in Action View Pricing

Part of Risk & Vigilance

Risk Management Complaint Handling Field Safety Notices Recall Management Dispenser Risk Management

Key Capabilities

What you get with the Adverse Event Reporting module.

Structured adverse event intake with reportability assessment

Regulatory reporting timelines with automated deadline tracking and alerts

Support for EU MDR vigilance, FDA MedWatch, and other global reporting formats

Investigation tracking with root cause analysis and risk reassessment

Trend monitoring to detect emerging safety signals across event data

See Risk & Vigilance in action

Watch how MoniDoseQMS handles risk & vigilance workflows end-to-end.

5:00

Risk & Safety

Risk Management

Walk through MoniDoseQMS's risk management module — create risk assessments based on ISO 14971, score probability and severity, apply control measures, and track residual risk with full traceability.

How It Connects

Adverse Event Reportingdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

Risk Management Complaint Handling Field Safety Notices

Ready to see Adverse Event Reporting in action?

Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Adverse Event Reporting works within your specific compliance context.

Book a Demo Find Your Requirements

More in Risk & Vigilance

Explore other modules in the Risk & Vigilance category.

Risk Management

Implement a complete ISO 14971-compliant risk management process from hazard identification through post-production monitoring. Maintain living risk management files with dynamic risk matrices and full traceability to risk controls and verification activities.

Complaint Handling

Capture, investigate, and resolve product complaints with built-in regulatory reporting workflows. Ensure timely investigation and link every complaint to risk assessments and CAPA actions for continuous improvement and full regulatory compliance.

Field Safety Notices

Prepare, approve, and distribute field safety notices efficiently when corrective actions in the field are required. Manage the entire FSN lifecycle from drafting through distribution tracking, ensuring affected customers and authorities are notified promptly.

Recall Management

Coordinate product recalls and field safety corrective actions with a structured process that ensures rapid response and complete traceability. Track affected units, manage customer notifications, and document the entire recall from initiation through closure.

Dispenser Risk Management

Apply risk management to dispensing and drug delivery devices with specialized hazard analysis addressing dose-related risks, device-drug interactions, and patient use errors. Maintain risk management files that address the unique risk profile of dispensing devices.