Train as You Build
Comply as You Grow.
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.
Wat the Academy
Offers.
The Academy is your built-in training system: role-based micro-courses, tracking, and certificates — including the evidence auditors actually want to see.
Knowledge + audit evidence, automatically. No extra effort.
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.
Did you Know?
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?
Role - Based Trainings
EASY13485 Role-Based Training provides structured, hands-on qualification
for all key roles in an ISO 13485 and MDR-compliant QMS.
Each role focuses on real responsibilities, regulatory expectations,
and day-to-day execution — supported by examples, knowledge checks,
and certificates that create audit-ready evidence.
While optimized for IPP EASY13485, all qualifications can also be used
as proof of basic competence for any ISO 13485 QMS.
Role-specific & Practical
Each training is tailored to a concrete role —
from CEO and QMR to R&D, Risk, Clinical, Regulatory,
Manufacturing, IT, and Cybersecurity.
Audit-ready evidence
Built-in tests, completion tracking, and certificates
create documented competence auditors expect to see —
without extra tools or manual follow-up.
Accesible & flexible
Free for EASY13485 subscribers, students, and interested professionals.
Courses are provided in German and can be completed in English
using browser translation.
PLC- Process Trainings
The EASY13485 PLC Process training covers the entire product life cycle and provides the foundation for your Technical Documentation in line with MDR Annex II. Instead of abstract theory, the courses guide you step by step through every development phase — reducing the need for external consulting just to understand basic regulatory tasks.
Plan Development
Define scope, strategy, intended use, and regulatory context.
Define Design Input
Translate requirements, risks, and user needs into design inputs.
Develop Product
Structured development across disciplines — from concept to design outputs.
Verify Product
Ensure design outputs meet defined inputs with traceable evidence.
Validate Product
Demonstrate fitness for intended use and clinical relevance.
Design Transfer
Prepare manufacturing, handover, and controlled release.
Maintain & Update Product
Change control, post-market feedback, and continuous improvement.
Together, these phases form the backbone of your
Technical Documentation — from intended use
to Declaration of Conformity.
Explore the PLC training →
Keep all training & compliance evidence in one place
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.
- Custom course library for internal SOPs & workflows
- Role-based access & automated reminders
- Exportable training matrix & certificate registry
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Discover
The Makerspace
⚙️
QMS-Service
Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.
🎓 Academy
🎓
Academy
Designed to develop high potentials—like top consulting firms—the Academy turns training into a strategic growth tool.
📄
Tech-Doc.
Consultants are used strategically, not permanently.
💻 Certificator.AI
Answers in seconds, so teams stay in flow and budgets stay lean.
🧾 Audit Support
Confidence on audit day—fewer findings, fewer costly loops.
OR
First Contact -
Your Choice
First Contact -
Your Choice
Start smart. Choose how you want to begin.
For startups, we offer a simple entry into professional compliance and quality management:
E-Learning & free Consulting call
Build the right foundation and get rewarded.
- “16 Obligations of a Manufacturer” course
- Certificate after completion
- First consulting call included – free
Direct Consulting
Start immediately with tailored expert support.
- First consulting hour: €162
- No prerequisites
- Startup-focused, practical guidance
Office hours
Monday to Friday
8:00 am - 2:00 pm
8:00 am - 2:00 pm