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
"Zechmeister Strategic Solutions supported Lumetry Diagnostics throughout our MDR compliance and certification journey for a COPD-focused device. The team combined clear regulatory strategy with pragmatic execution, helping us choose cost-effective pathways and avoid unnecessary loops. That focus materially accelerated our certification timeline."
"During our ISO 13485 implementation, Zechmeister Strategic Solutions translated complex requirements into practical, efficient processes our team could actually run. Their structured approach and attention to detail improved our day-to-day operations and left us audit-ready with a QMS that truly works."
"For our novel diagnostic device, Zechmeister Strategic Solutions delivered a sharp market entry plan that connected regulatory requirements with business reality. They brought senior-level expertise, asked the right questions early, and gave us a clear path to launch with fewer surprises."
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.