Meet Your EU MDR Navigator
Tibor Zechmeister
Founder & Lead Regulatory Expert
Lead Auditor - Notified Body
MDR Certified
15+ Years MedTech
Founded 4 MedTech Companies
- Lead Auditor at EU Notified Body
- 15+ years Medical Device Regulatory Affairs experience
- 50+ successful EU MDR certifications guided
- Former Founder and Head of Regulatory at international MedTech company
- State accredited MDR - QMS expertise
"Our team has seen the EU MDR certification process from both sides - as Notified Body auditors and as manufacturers. This dual perspective allows us to prepare your documentation exactly the way auditors expect it, eliminating costly revision cycles."
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For specific questions that don’t need a full call, send us an email directly.
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Common Questions
About the Strategy Call
30 minutes. Enough time to understand your situation and give you real value.
Yes, completely. No obligation, no sales pressure.
Know your product class (or we help determine it), your timeline goals, and your approximate budget.
You receive a summary with recommended next steps. You decide if and when to proceed.