Matrix Requirements and Galen data join forces to become Matrix One
Design-Connect-Launch
your medical device with our all in one solution
The all-in-one platform for a streamlined medical device compliance














































































































































































































































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Why choose Matrix One ?
Medical device companies operate in one of the most complex, high-stakes industries—where speed, compliance, and collaboration are non-negotiable. Matrix One is purpose-built to help you navigate these demands with confidence.
Centralized documentation and version control
Automated workflows aligned with ISO and FDA standards
Real-time collaboration for faster decision-making
Seamless collaboration across RA/QA, Engineering, and Product
Traceable design history files and risk management integration
Reduced rework and audit readiness from day one
Real-time data synchronization across teams
Integrated communication tools for seamless interaction
Built-in compliance support to standards like ISO 13485 and IEC 62304
Automated documentation to ensure traceability

Customizable workflows to fit your specific needs
Quick adaptation to changing regulatory requirements
Secure cloud storage for easy access and sharing
Comprehensive data analytics for informed decision-making
