Complaint Handling
Capture, investigate, and resolve product complaints with built-in MDR vigilance and FDA MDR reporting workflows. Ensure timely regulatory reporting and link every complaint to risk assessments and CAPA actions for continuous improvement.
Key Features
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Related Modules
CAPA Management
Streamline your Corrective and Preventive Action process from identification through effectiveness verification. Integrate root cause analysis tools and track every CAPA to closure with full traceability across complaints, audits, and nonconformances.
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 automatic residual risk recalculation.
Post-Market Surveillance
Establish a proactive post-market surveillance system that meets EU MDR Article 83-86 requirements. Aggregate data from complaints, vigilance reports, literature, and registries to generate PMS plans, PMSR/PSUR reports, and trend analyses.