We build competence into your company’s DNA from day one — keeping your team qualified and audit-ready for every inspection.
Don’t bolt e-learning on later — start right, grow with training.
From your first design review to post-market surveillance, the Academy equips your team to run, scale, and audit-proof your QMS — while saving time and consultant costs.
Role-Based Trainings
Clear rights and obligations under ISO 13485 and MDR so every role stays qualified and compliant.
Process Trainings for Startups
Go from idea to documentation with guided templates — bring in consultants only at high-impact steps.
Expert Trainings
Deep-dives across Quality Management, Regulatory Affairs, Risk Management, and more.
Learn the essentials, build your documentation, and let our consultants step in only where they add the most value. Faster setup, lower costs, no compromise on quality.
Role & process courses embed QMS know-how directly in your team.
Use EASY13485 templates to create documentation in-house—faster and cheaper.
Bring our consultants in only for milestones & sanity checks—stay on track with less cost.
Under EU MDR Article 10(9), manufacturers are obliged to ensure all relevant staff are trained, competent, and documented in their QMS responsibilities. Many teams overlook this early — leading to costly, last-minute fixes before audits.
Want to know your exact obligations as a manufacturer under Article 10 & 16?
Take the Short Manufacturer Obligations AssessmentTraining is embedded directly into your QMS—not a separate system. That means role-based assignments, built-in evidence, and no context switching.
From day one, you get traceable learning paths mapped to MDR/ISO requirements, so audits become routine instead of stressful.
Modules mapped to roles and processes.
Certificates and records auto-logged.
Add SOPs and templates anytime.
Host your individual Academy workspace for ongoing training and tracking of internal processes. Assign courses, store certificates, and track audit readiness—all in a single hub fully aligned with your QMS.
Centralized certificates tied to users, roles, and processes—searchable and exportable.
Completion, scores, and dates logged automatically for each assigned module.
Every record is traceable to the relevant QMS process for clear audit trails.