Evolunic was built for medical device teams that have outgrown spreadsheets and disconnected tools. When V&V evidence lives in one place, drawings in another, and requirements in a third — compliance becomes a scramble instead of a workflow.

Our team combines deep expertise in medical device development, software engineering, and regulatory compliance. We understand what it takes to get through ISO 13485 audits, FDA submissions, and EU MDR technical files — and we built EIS to make that work continuous, not a pre-audit sprint.

We're security-first by design. Every customer runs on a single-tenant deployment with a private knowledge base over their own standards, device history records, and past projects — your IP never co-mingles with another team's, and never trains a foundation model.