Our Services
Authorized representation for medical devices — a representative network covering the EU, the United States and Brazil.
European Authorized Representative (EC-REP)
Your mandatory EU representative under MDR/IVDR: representation agreement, EUDAMED registration & SRN, label review, incident reporting & FSCA coordination, Certificates of Free Sale.
PPWR Packaging Authorized Representative
Written mandate under the EU Packaging and Packaging Waste Regulation (EU) 2025/40, plus EPR registration support for packaging placed on the EU market.
US Agent
FDA-required US Agent for foreign establishments: establishment registration & device listing, FDA correspondence and inspection support.
Brazilian Registration Holder (BRH)
ANVISA-required Brazilian Registration Holder (BRH) services: registration, import compliance and post-market maintenance.
More services are in the pipeline — tell us what you need via Contact Us.
Not sure which service you need?
Tell us about your products and target markets — we will map your compliance route.