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The Matrix Requirements Platform
Our easy to use, flexible software platform allows all teams to quickly document requirements & become compliant
MatrixALM
Build regulated software with an agile application lifecycle management tool made for medical devices. Ensure compliance is never a barrier to innovation.
Easily capture all design inputs and outputs
Generate DHF & Technical Files with a few clicks
Traceability across requirements, specs, tests & risks
Compatible with IEC 62304, 62366, ISO 14971 and more!
MatrixQMS
Navigate the complex regulatory landscape with an intuitive and fully customizable quality management system (eQMS).
Ensure compliance and product quality
Quickly write, review, and publish your quality manual
Manage quality records like CAPAs, supplier, audits and more
Full traceability from standards to processes
Galen Cloud
Centralize data and leverage cloud technologies with our turn-key, configurable, scalable, and easy-to-use platform. Focus on medical innovation without needing to become experts in software design, data storage infrastructure, cyber-security and global regulations.
Collect and securely store data
Visualize and analyze patient and device data
Ensure FDA and global regulatory compliance
HIPAA/GDPR and ISO 13485:2016 Certified
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