Diagnostic Equipment with Matrix Requirements®
As diagnostic technology evolves, so do the expectations for traceability, documentation, and compliance. Matrix Requirements® empowers development teams to meet these demands.
The challenge
Our solution
Core Features
Purpose-built capabilities for diagnostic equipment development teams.
End-to-End Design ControlManage all design elements: inputs, outputs, tests, and risks in a structured, traceable database. Link every design decision to its regulatory rationale and keep your design history file always up to date.
Multi-Disciplinary TraceabilityMaintain traceability across hardware, software, and connectivity components in a single project. Instantly surface the impact of any change across your full design from component level to system level.
Risk Management for Diagnostic DevicesConfigure risk assessments tailored to your device type and classification — with support for ISO 14971 workflows, pre- and post-control assessments, and full traceability between risks and mitigations.
Regulatory Standards CoverageNavigate IEC 60601, IVD regulations, EU MDR, FDA 510(k), and other regional requirements with confidence with built-in support for the documentation and traceability these standards demand.
Technical Documentation GenerationGenerate audit-ready technical files automatically from your live project data in PDF, Word, or HTML and archive them securely for regulatory submissions.
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
