Pick a few basics about your startup and product. The calculator recommends the right Easy13485 setup and shows a transparent monthly breakdown (excl. VAT) — so you can immediately understand what drives the price.
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.
Select your setup to get a recommended solution and monthly price (excl. VAT).
Easy13485 delivers out-of-the-box speed with the flexibility to match each team’s unique setup.
Built to develop high potentials, the Academy turns training into a strategic growth tool.
Consultants are used strategically, not permanently.
Answers in seconds, so teams stay in flow and budgets stay lean.
Confidence on audit day – fewer findings, fewer costly loops.
Start smart. Choose how you want to begin.
For startups, we offer a simple entry into professional compliance and quality management.
Build the right foundation and get rewarded.
Start immediately with tailored expert support.
