Tibor Zechmeister | EU MDR Expert & MedTech Entrepreneur

Tibor Zechmeister / Founder & EU MDR Expert

My Story

From Engineer to 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.

Qualifications

Credentials & Experience

Biomedical Engineering Background

~15 Years in European MedTech Sector

Accredited Notified Body Lead Auditor

QMS & Technical Documentation

Founded 4 Medical Device Companies

Advised 50+ International Companies & Startups

Co-Author of MDR Specialist Publications

Speaker at International MedTech Conferences

Chair of the Austrian Regulatory Affairs Professional Society LNG

Austrian State Prize Winner

Category Innovation

Journey

Key Milestones

2010

Started in MedTech

Beginning the journey

2011

Founded First Company

Entrepreneurial leap

2022

Became NB Lead Auditor

Certified expertise

2025

50+ Companies Guided

Proven track record

Approach

How I 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. I 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.

“The right strategy and ecosystem partnerships make the difference between a certification that drags on for years – and one that succeeds efficiently.”

Tibor Zechmeister

75%

Faster Market Entry

70%

Cost Reduction

What I Offer

Services

EU Market Entry

Strategic guidance for international companies entering the European medical device market under EU MDR.

First Certification

End-to-end support for startups and companies pursuing their first CE marking under the new regulatory framework.

QMS Implementation

Pragmatic quality management system setup aligned with ISO 13485 and EU MDR requirements.

Technical Documentation

Structured technical documentation that meets Notified Body expectations and accelerates the review process.

Clinical Evidence Strategy

Clinical evaluation planning and evidence strategies that satisfy regulatory requirements efficiently.

Workshops & Keynotes

Engaging presentations and hands-on workshops on EU MDR, regulatory strategy, and MedTech innovation.

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Trusted by Industry Leaders

What Clients Say

Manuel Leal Garcia

Head of Business Development, Aurimod

“Tibor's practical approach to EU MDR compliance was exactly what we needed. His ability to break down complex regulatory requirements into actionable steps inspired confidence across our entire team. His insights have been invaluable for our market strategy.”

Antonia Riva-Frizberg

Co-CEO & Co-Founder, Lumetry Diagnostics

“Working with Tibor transformed our approach to regulatory compliance. He provided cost-effective, pragmatic approaches that saved us significant time and resources. His deep understanding of both the regulatory landscape and startup dynamics is truly exceptional.”

Uros Tacar

CEO; QA & RA Professional; Lead Auditor

“Tibor's proactive nature and commitment to excellence set him apart in the MedTech industry. His strategic guidance has been instrumental in helping organizations navigate the complex regulatory environment. A true leader in the field.”

Stefan Kampusch

CEO, AURIMOD GmbH

“Tibor's unique blend of regulatory expertise and entrepreneurial spirit makes him an exceptional partner. He doesn't just understand the rules – he understands the business realities of bringing medical devices to market. His support has been a game-changer for us.”

TiborZechmeister

50+

15

Certified

75%