Your Strategic Partner for EU MDR Certification
Whether you're an international company entering the EU market or an Austrian startup seeking your first CE mark – we guide you through EU MDR certification efficiently and transparently.
Which Challenge Are You Facing?
International Market Entry
You have FDA, TGA, or other international certification and want to enter the European market.
- For companies with €5-60M revenue
- Existing documentation & QMS
- Goal: Fast EU MDR certification
First Certification
You're an Austrian startup with innovative technology seeking your first CE mark.
- Funding €200k-2M (FFG, aws, Regional Funding)
- Building from scratch
- Goal: CE marking & market launch
What Makes Us Different
One point of contact for everything: Notified Bodies, clinical studies, testing labs, technical documentation. No coordination chaos.
Up to 75% faster market entry. Up to 70% cost reduction through strategic partnerships.
We work WITH your team, not FOR you. Knowledge transfer ensures your team builds lasting expertise at every step.
Clear timelines and costs from day one. No surprises, no hidden fees. You know exactly what to expect.
What Our Clients Say
"I had the pleasure of working with Tibor at Lumetry Diagnostics GmbH in 2023. As an external consultant, he continuously supported our team with regulatory compliance and helped us navigate the certification process for our COPD-specialized medical device. Tibor's thoughtful strategic planning helped us find cost-effective approaches, significantly shortening our certification timeline."
"I wholeheartedly recommend Tibor, as he guided Vertify GmbH from 2020 to 2022 through the meticulous process of implementing an ISO 13485 certified quality management system. Tibor's deep knowledge and strategic thinking were crucial in translating complex regulatory requirements into practical, efficient procedures that significantly enhanced our operational effectiveness."
"I had the pleasure of working with Tibor at Robot Dreams GmbH in 2023. We brought him on board to analyze and plan the market launch of our novel diagnostic medical device. Tibor distinguished himself through exceptional professionalism and expertise, seamlessly connecting regulatory insights with practical business strategy."
Subtract to Ship: MDR
The MedTech Founder's Regulatory Playbook
The regulation does not kill MedTech startups. The approach does. An EU MDR playbook written from both sides of the table. Felix Lenhard has shipped 12 products of his own to 50+ countries and coached more than 100 startups to market. Tibor Zechmeister is a Notified Body Lead Auditor and four-time MedTech founder who has guided 50+ companies through MDR certification. One knows what founders actually struggle with. The other knows what auditors actually check. You get both.
- 20 chapters covering the full path, from "is this even a medical device?" to post-market surveillance
- 20 ready-to-use templates, one for each chapter
- The Two-Phase Approach, the Double-It Rule and honest cost ranges for Class I through Class III
- Real case studies with real numbers, a 52-week action plan and the complete MDR decision tree
Every article reference has been verified against the consolidated text of Regulation (EU) 2017/745 and reviewed by a Notified Body Lead Auditor.
Ready to Start Your EU MDR Journey?
Book a free strategy call to discuss your specific situation, get a realistic timeline, and understand the costs involved.