Webinar: Connecting your Device to the Cloud: A Primer on Matrix Connect
Risk Management in Matrix Req
Identify, assess, and mitigate risks with confidence — fully traceable, fully compliant, and built for medical device teams.
The challenge
Our solution
Core Features
Purpose-built tools to manage every aspect of your medical device risk process.
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.
Risk ControlConfigure any design category as a risk control and link it directly to the relevant risk — keeping mitigation measures always traceable.
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.
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
