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

Request A Demo Today













































































































































































































































Thank you
A member of our team will be in contact within 48 hours.
Stay up to date with our latest success stories.
Take a look at how Limbus AI cuts time to market with their innovative deep-learning solution for CT contour delineation.
Matrix One is trusted by 300+ Medical Device Companies Globally
















































































Why choose Matrix One ?
Accelerate Regulatory Approval. Drive Cross-Functional Excellence. Medical device companies face intense pressure to innovate, meet compliance standards, and bring devices to market faster—all while ensuring internal teams are aligned. Matrix One is purpose-built to address these challenges.
For RA/QA TeamsSpeed Up Regulatory Time-to-Market — Without Sacrificing Compliance
Centralized documentation and version control
Automated workflows aligned with ISO and FDA standards
Real-time collaboration for faster decision-making
For R&D LeadersInnovate Confidently — With Built-In Regulatory Alignment
Seamless collaboration across RA/QA, Engineering, and Product
Traceable design history files and risk management integration
Reduced rework and audit readiness from day one
Product Features
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
