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.
Traceability Checker
Finds risks with no mitigation and mitigations with no verification, judges whether existing links really hold, and suggests what should fill each gap.
Learn moreHear 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
