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.

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Part of Risk & Vigilance

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

Regulatory Context

ISO 14971:2019 — Application of risk management to medical devices

EU MDR Annex I — General safety and performance requirements

ISO/TR 24971:2020 — Guidance on the application of ISO 14971

Key Capabilities

What you get with the Risk Management module.

Dynamic risk matrices with configurable severity and probability scales

Hazard identification linked to design inputs, complaints, and field data

Risk control measure tracking with verification and validation evidence

Benefit-risk analysis documentation for EU MDR compliance

Post-production risk monitoring with trend detection and automatic alerts

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 Risk Management helps your organisation.

Proactively identify and mitigate safety hazards before they reach patients

Strengthen regulatory submissions with a complete, living risk management file

Reduce post-market surprises through continuous risk monitoring and trend detection

How It Connects

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

CAPA Management Complaint Handling Benefit-Risk Analysis

Ready to see Risk Management in action?

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

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More in Risk & Vigilance

Explore other modules in the Risk & Vigilance category.

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.

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.