Company Performance Metrics
Regi is a SaaS platform that provides AI-assisted regulatory execution workflows for teams building Software as a Medical Device and AI-enabled medical devices. The platform helps users interpret and apply regulatory requirements by converting them into structured, step-by-step workflows aligned to UKCA, EU MDR/IVDR, and FDA frameworks.
Product teams, consultants, and multi-product organizations use Regi to build and maintain documentation such as PMS plans, clinical evaluation materials, and risk management files. Guided document wizards, guidance panels, and AI Assist support hazard identification, classification, evidence planning, and post-market surveillance. The system keeps inputs, risks, evidence, and traceability links synchronized across modules, supporting both pre-market preparation and ongoing post-market activities. Regi is designed to work alongside existing QMS and regulatory information management tools.
