Your Compliance Expert — On Demand
Skip the scheduling. Ask Certificator AI your MDR & ISO 13485 questions and get instant, standards-based answers—right where you work.
The Waiting Game Costs You
Consultant time is precious—so is your momentum. Waiting for availability stalls work and turns small doubts into big delays.
- Days lost to scheduling and back-and-forth
- Blocked tasks across design, risk, and documentation
- Costs rising for questions that should take minutes
Every day you wait for an answer, engineering, regulatory, and quality teams stall. Certificator AI removes that bottleneck.
Ask
“What do I include in the Management Review?” “How do I define Intended Use?”
Get
Standards-based guidance with references and step-by-step actions.
Do
Fill templates correctly, move tasks forward, and stay audit-ready.
Leapfrog the Bottleneck
Certificator AI is trained on MDR, ISO 13485, ISO 14971, IEC 62304, and the EASY13485 framework—so you get accurate, contextual answers in seconds.
- Ask Anytime: No booking, no delay—24/7 availability
- Context-Aware: Guidance aligned to your roles, processes, and templates
- Cost-Efficient: Use consultants for milestones; use AI for daily questions
Why teams love Certificator AI
Instant Answers
No waiting—get guidance in seconds, any time.
Process-Aware
Answers align with your EASY13485 processes & roles.
Save Consultant Hours
Use experts for milestones, AI for daily clarification.
Audit Support
Guidance that helps you stay compliant and confident.
Built for Manufacturers
Aligned with MDR & ISO 13485. Designed to support—not replace—audits and internal reviews.
Verified Guidance
Continuously curated by our regulatory & quality experts and maintained with current best practices.
Stop waiting. Start certifying.
Ask Certificator AI anything about MDR & ISO 13485 and move your work forward—today.
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