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 & Vigilance

Risk Management Adverse Event Reporting Field Safety Notices Recall Management Dispenser Risk Management

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

See Risk & Vigilance in action

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

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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.

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 & 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.

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.

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.