Services
Every stage of EU market entry, through a single contact point.
A typical journey
- 1MDR review & gap analysis→
- 2Clinical investigation support→
- 3CE marking support→
- 4AR & post-market support
Regulatory Services
From MDR strategy and gap analysis to technical documentation — we design your path to CE marking.
Clinical Investigation Support
From Legal Representative services for non-EU sponsors to submission preparation and ethics committees — we support your EU clinical investigation end to end.
EU Authorized Representative (AR)
From AR registration to technical file custody and authority liaison — your Article 11 MDR obligations covered under an annual agreement.
QMS Services
From MDR gap analysis to SOP review, internal audits and CAPA — continuous support for MDR-compliant quality management.
Investigational Device Logistics
Receipt, storage and hospital delivery of investigational devices in Europe — including traceability and end-of-study returns.
Start with a free 30-minute consultation
We help you map your current position: device class, CE status, and EU clinical investigation plans.
Book a free consultation