Risk Management in Matrix Req
Identify, assess, and mitigate risks with confidence — fully traceable, fully compliant, and built for medical device teams.
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The challenge
Risk management is too complex to handle without the right structure
Managing risks across a medical device development project is inherently complex. Teams must track risk inputs, assess acceptability before and after controls, link mitigation measures, and maintain full traceability — all while meeting ISO 14971 and other regulatory standards. Without a dedicated system, this process is fragmented, error-prone, and hard to audit.
- Hard to customizeDifferent device types require different risk parameters — probability, severity, detectability — and most tools don't allow flexible configuration.
- Difficult to traceLinking risks to controls, requirements, and tests across the project manually is time-consuming and unreliable.
- Slow to reportProducing 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
Matrix Req's Risk Module lets you define your own risk formula, configure multiple risk layers, and link every risk to its control measures — all within the same platform as your requirements and tests. Risk traceability is maintained automatically, and live dashboards give your team instant visibility into your risk landscape.
- Configure risk your waydefine parameters, formulas, and risk categories that match your device and regulatory strategy.
- Trace every riskto its controls, requirements, and tests — automatically and in real time.
- Stay audit-readywith 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 Report
Visualize 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 Assessment
Auto-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 Control
Configure any design category as a risk control and link it directly to the relevant risk — keeping mitigation measures always traceable.
Risk Configuration
Define 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
