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.

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Part of Risk & Safety

Risk Management Benefit-Risk Analysis Adverse Event Reporting Field Safety Notices Recall Management Safety Data Sheets Return Material Authorizations

Regulatory Context

ISO 13485:2016 §8.2.1 — Feedback (including complaints)

EU MDR Article 87 — Reporting of serious incidents and field safety corrective actions

FDA 21 CFR Part 820.198 — Complaint files

Key Capabilities

What you get with the Complaint Handling module.

Multi-channel complaint intake with automated acknowledgment and triage

Risk-based investigation workflows with root cause determination

Regulatory reporting support for EU MDR vigilance and FDA requirements

Automatic escalation to CAPA when severity thresholds are met

Trend analysis across product families, complaint types, and failure modes

Why It Matters

How Complaint Handling helps your organisation.

Improve customer satisfaction by resolving complaints faster and more consistently

Meet vigilance reporting deadlines with built-in regulatory submission workflows

Turn complaint data into actionable product improvements through trend analysis

How It Connects

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

CAPA Management Risk Management Adverse Event Reporting

Ready to see Complaint Handling in action?

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

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More in Risk & Safety

Explore other modules in the Risk & Safety 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.

Benefit-Risk Analysis

Systematically evaluate the clinical benefits of your products against their residual risks to support regulatory submissions and market access decisions. Document your benefit-risk determination in a structured format that meets EU MDR and global regulatory expectations.

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.

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.

Safety Data Sheets

Manage and distribute safety data sheets for chemicals, materials, and hazardous substances used in your manufacturing and operations. Ensure compliance with GHS requirements and give your teams instant access to critical safety information.