UE Representation

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.

Commercial Network

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.

MDR Consulting

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.

Get a personal consultation.

We will take care of your medical product business worldwide