Your European partner for MedTech innovators

We help MedTech startups and manufactureres turn complexity into clarity — and ideas into approved devices — to enable better health.

This is where Qmed makes the difference. We’re not just a CRO. We’re a partner.

Since 2006, we’ve guided startups and manufacturers through the EU and US regulatory landscape. With 100+ successful projects and a client retention rate above 70%, we’re entrusted to bring forth some of world’s most innovative medical devices.

Hear from our founder and CEO, Helene Quie, what Qmed’s mission is and why Medtech innovators choose us.

Based in Scandinavia, Qmed is centered in Medicon Valley and rooted in Denmark’s tradition of trust, quality, and innovation. From this base, we conduct projects across the entire European Union, guiding MedTech companies through diverse regulatory landscapes and clinical environments. Our strength lies in Europe — it’s where we know the systems, the sites, and the regulators better than anyone. But our work doesn’t stop at the EU border. We also support approvals in the US and have established partnerships with trusted collaborators who ensure your device is ready for both markets.

Wherever you are in your MedTech journey, we help you move forward

1Plan

Lay the foundation with the right regulatory and clinical strategy. We help you ask the critical questions early, align investors, and map a path that avoids costly surprises later.

2Execute

Design and run clinical studies with foresight. From site selection to trial management, we ensure your evidence is built on quality, efficiency, and compliance.

3Approval

Navigate submissions with confidence. We prepare and manage documentation and interactions with Notified Bodies, Competent Authorities, and Ethics Committees — to get it right the first time.

4Market

Support doesn’t stop at approval. We guide post-market studies, vigilance, and reimbursement strategies — so your innovation succeeds long after launch.

Our project log

What some of our clients say

Johannes Petersen

CFO of TECHNO

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