Who it is for
Shipments and registrations that must clear customs and national or EU MDR gates, including certificate pathway coordination with manufacturers and local agents.
Regulatory compliance
Export documentation, EU MDR or national registration pathways, HS classification and country-specific dossiers.
Next step
Scope
What is included
The scope of services is tailored to each client and is not limited to the activities listed below. Specific priorities, deliverables and responsibilities are agreed in writing before work begins.
- 01
Document ownership matrix
- 02
Conformity documentation review
- 03
HS classification support
- 04
Dossier assembly with local regulatory experts
- 05
CE / FDA / ISO / MDR pathway notes
- 06
Honest regulator-dependent timelines
What you get at the end
A submission-ready compliance package your broker, agent and regulator can work from, with owners named in advance, and a clearer path into tenders where registration is the gate.
Next step
Ready to scope this work?
Send the device category, market and timeline. We reply with what this service covers for your case.