From Engineer to Your Strategic Partner
My journey in medical devices started with a biomedical engineering degree and a passion for healthcare innovation. Over nearly 15 years, I've experienced the MedTech industry from every angle.
I've founded 4 companies in the medical device space – so I understand the entrepreneur's perspective: limited resources, time pressure, and the need for pragmatic solutions.
As an accredited Lead Auditor for a Notified Body, I've reviewed countless quality management systems and technical documentation files. I know exactly what auditors look for and why applications fail.
Today, I combine all this experience to help international companies and startups master the EU MDR in the shortest possible time.
Credentials & Experience
(QMS & Technical Documentation)
(Category Innovation)
Faster market
entry
Total project costs
reduced
"The right strategy and ecosystem partnerships make the difference between a certification that drags on for years – and one that succeeds efficiently."
— Tibor ZechmeisterHow We Work
Transparency First
No buzzwords, no inflated promises. You get realistic timelines, honest cost estimates, and clear communication about what's achievable.
Co-Creation, Not Ghostwriting
Your team has the product knowledge. We bring the regulatory expertise. Together, we create compliant documentation that your team actually understands.
Results Over Process
The goal is your CE certificate, not beautiful PowerPoint presentations. Every step we take is focused on getting you certified efficiently.
Key Milestones
Beginning the journey
Entrepreneurial leap
Certified expertise
Proven track record
Let's Discuss Your Project
Ready to work with someone who's been on both sides of the audit table?