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Risk Management in Matrix Req

Identify, assess, and mitigate risks with confidence — fully traceable, fully compliant, and built for medical device teams.

Matrix Requirements
The challenge
Our solution

Risk management is too complex to handle without the right structure

A fully configurable risk module — built into your design control workflow

  • Hard to customize

    • Different device types require different risk parameters — probability, severity, detectability — and most tools don't allow flexible configuration.

  • Configure risk your way

    • define parameters, formulas, and risk categories that match your device and regulatory strategy.

  • Difficult to trace

    • Linking risks to controls, requirements, and tests across the project manually is time-consuming and unreliable.

  • Trace every risk

    • to its controls, requirements, and tests — automatically and in real time.

  • Slow to report

    • Producing up-to-date risk reports for regulatory submissions or internal reviews requires significant manual effort.

  • Stay audit-ready

    • with structured risk records, timestamped assessments, and exportable reports.

    The challenge

    Risk management is too complex to handle without the right structure

  • Hard to customize

    • Different device types require different risk parameters — probability, severity, detectability — and most tools don't allow flexible configuration.

  • Difficult to trace

    • Linking risks to controls, requirements, and tests across the project manually is time-consuming and unreliable.

  • Slow to report

    • Producing up-to-date risk reports for regulatory submissions or internal reviews requires significant manual effort.

    Our solution

    A fully configurable risk module — built into your design control workflow

  • Configure risk your way

    • define parameters, formulas, and risk categories that match your device and regulatory strategy.

  • Trace every risk

    • to its controls, requirements, and tests — automatically and in real time.

  • Stay audit-ready

    • with structured risk records, timestamped assessments, and exportable reports.

    Core Features

    Purpose-built tools to manage every aspect of your medical device risk process.

    Risk Follow-Up & Traceability ReportVisualize your risk landscape with live Risk Matrix and Risk Stats dashboards. Track risk levels across the lifecycle and export directly into your documents for streamlined reporting.
    AI-Driven Risk AssessmentAuto-Generation: Produce risk assessments and mitigations with minimal manual effort. Full Coverage: Ensure comprehensive risk coverage across your product lifecycle. Human-in-the-Loop: Validate every AI-generated item before it is applied.
    Risk ControlConfigure any design category as a risk control and link it directly to the relevant risk — keeping mitigation measures always traceable.
    Risk ConfigurationDefine multiple risk layers with your own parameters, formula, and acceptability criteria — tailored per device and risk category.

    • Risk Input: Define factors and how they combine to assess risk acceptability.

    • Pre-Control Assessment: Evaluate risk before any controls are applied.

    • Risk Controls: Link design items as risk control measures directly within the project.

    • Post-Control Assessment: Re-assess risk acceptability after controls are applied.

    Hear from our customers

    With Matrix Req, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”

    François Audéon, Chief Technology Officer

    Matrix One is trusted by 500+ Life Sciences & Medical Device Companies