For Start-ups companies and small manufacturers, submission to CE marking to real-world adoption — the journey into the EU market is both rigorous and rewarding.
Over the past year, we at Starodub have supported several MedTech companies in achieving regulatory approvals across Europe. And while success in the EU is often measured in certificates and notified body approvals, the true impact goes far beyond documentation. Each approval represents: Strategic preparation, Deep understanding of the MDR framework, Regulations and Standards, Strong technical documentation, Proactive risk and clinical planning, Cross-functional alignment and clear communication.
Expanding into the EU market under the Medical Device Regulation (MDR) is no small step. The expectations are higher, scrutiny is deeper, and timelines require realistic planning. But complexity doesn’t have to mean uncertainty.
With the right regulatory roadmap, early gap assessments, and clear market entry sequencing, EU expansion becomes a structured process — not a guessing game. Because in Europe, regulatory excellence isn’t just about compliance. It’s about credibility, sustainability, and long-term market presence.
Let Starodub team of experts support you on your rewarding journey from development to final approvals, check out our website for the full list of services we can provide https://www.starodub.nl/ or send an enquiry for more information to [email protected] . Together we are Stronger.
