Matrix One is a software company serving medical device, IVD and life science manufacturers. The platform brings together Matrix Req for requirements and design control, Matrix Quality for electronic quality management, Matrix eIFU for electronic instructions for use, and Matrix Connect for connected device data. Teams use it to build traceable design history files, run document and training control, publish compliant labelling, and stay audit ready for ISO 13485, ISO 14971, IEC 62304, EU MDR and FDA 21 CFR Part 11 and Part 820. Founded in 2014, Matrix One works with startups through to global manufacturers.
Phone Number:
+1 888 372 9175
Business Email:
marketing.matrix@matrixreq.com
Business Hours:
Mon - Fri : 09:00 AM - 05:00 PM
Sat - Sun : Closed
Features or Services
Requirements Management Software, Medical Device Software, eQMS Software, Quality Management System Software, Design Control Software, ALM for Medical Devices, ISO 13485 Software, IEC 62304, EU MDR Compliance Software, eIFU Software, Electronic Instructions for Use, Medical Device Connectivity, Traceability Matrix Software, Design History File Software