RegMetrics simplifies medical device regulation by guiding innovators step-by-step through classification, requirements, and standards needed for regulatory approval. The platform translates complex MDR and IVDR legal text into clear, yes-or-no questions and produces regulator-ready PDF outputs and interactive reports to support CE marking for European and UK markets.

Our web-based tool provides a free initial triage to determine whether a product is a medical device, followed by guided classification, a GSPR checklist, and standards identification. Deliverables include downloadable PDFs for technical documentation, interactive summaries for internal discussion, and links to testing houses. We also provide consultancy services, workshops, training materials, and enterprise plans for institutions.

Built by academics for academics, RegMetrics supports researchers, university translation teams, spin-outs, and startups. The company emphasises usability and upskilling, and works with universities and health-technology networks to reduce administrative overhead and accelerate safe innovation.