Your European partner
for MedTech innovation
We help MedTech startups and manufacturers turn complexity into clarity — and ideas into approved devices — to enable better health.
This is where Qmed makes the difference. We are not just a CRO. We are a partner.
Since 2006, we have guided startups and manufacturers through the EU and US regulatory landscape. With 900+ successful projects and clients who keep coming back, some for over two decades — we’re entrusted to bring forth some of the world’s most innovative medical devices.
Hear from our founder and CEO, Helene Quie, about our mission and why MedTech innovators choose us.
We’re a European consultancy and CRO, built for European market access.
Headquartered in Copenhagen and rooted in Medicon Valley, we have 100+ specialists strategically located around the EU — close to the sites, the regulators, and the innovation we help bring forward.
If you’re working towards CE marking, this is where we’re strongest. We know the MDR and IVDR landscape inside out, and we deliver both strategic guidance and clinical execution under one roof.
We also support US approvals and work with trusted partners when your path extends beyond Europe — but the EU is our home ground.
Wherever you are in your MedTech journey, we are here to 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.
3Market Access
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.
4Post-Market
Support doesn’t stop at approval. We guide post-market studies, vigilance, and reimbursement strategies — so your innovation succeeds long after launch.
900+
Projects across Clinical & Regulatory
400+
Class III devices supported
53K+
Patients in Clinical Studies
20
Years of experience in MedTech
What our clients say...
“We worked with Qmed to support clinical trial operations across multiple sites, where coordination and communication were important. The team was responsive and collaborative in facilitating interactions between sites and the sponsor.
Qmed provided operational support in site coordination and follow-up. Their structured communication and timely updates were helpful in maintaining alignment and oversight of study activities.”