Why We Built This
24 July 2026
We didn’t start out building a commercial product.
We started by solving our own problem: converting product data into EUDAMED-ready XML in bulk, without the endless hours of manual checking.
Along the way, we realized something: this wasn’t just our problem.
Small and mid-sized medical device manufacturers across Europe face the exact same scenario — limited technical staff, unclear business rules, and a system (EUDAMED) that offers no help with the transition.
So the tool became a service.
Validation before upload. MDR and legacy device coverage. Built on EUDAMED’s own logic, not assumptions.
Built by people who had to solve this themselves first.