1) Medical Device

Choose what you’re building (SaMD/software, non-active device, medical-electrical system, custom-made device). This sets the typical compliance scope and documentation needs.

2) Number of Employees

Select your team size. For larger teams, additional “team blocks” may be added automatically, because roles, onboarding, and QMS workload scale with headcount.

3) Risk Class

Pick the MDR class (I–III). Higher classes typically mean more structure, stronger traceability, and earlier audit readiness.

4) Requirement

Choose your goal: Training tool (onboarding + documented training), QM Service (work immediately in an audit-ready QMS), or Own QMS (build/extend your own QMS based on Easy13485).

5) Add-ons (optional)

Enable AI Act, ISMS (ISO/IEC 27001), or individual trainings. The calculator updates instantly and shows what’s included vs. optional.