As your official EU Authorized Representative, we ensure full compliance with MDR Article 31 requirements — giving you a legal foothold in Europe while managing vigilance, documentation, and regulatory correspondence on your behalf.
We don’t just help you enter Europe — we help you thrive. From identifying qualified distributors to setting up local partnerships, we build a tailored sales network that turns market access into real revenue.
From gap assessments to technical documentation and clinical evaluation, our MDR experts guide you through every step of compliance — efficiently, accurately, and with your business goals in mind.
Need a personalized solution?
Tell us about your device, your timeline, and your target markets — and we’ll design a regulatory and commercial roadmap that works for your business. Get in touch today.
Navigating the EU MDR doesn’t have to slow you down. We translate complex requirements into clear, actionable steps — so you achieve compliance without compromise.
Market Intelligence
We go beyond regulations to understand your market. From country-specific dynamics to distributor fit, we help you choose the right path — not just the fastest one.
A Commercial Strategy
Compliance opens the door — but sales close the deal. We support you in building a real, functional sales network across Europe, so your product reaches the patients who need it.
