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.

Keywords

Requirements Management Software Medical Device Software

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