Europe Markets

Complete MDR and IVDR compliance solutions for medical devices in the European Union market.

• CE Marking under MDR/IVDR
• Technical Documentation
• Clinical Evaluation Reports
• Notified Body Liaison

Comprehensive regulatory pathways for UK market access post-Brexit.

• MHRA Registration
• UKCA Marking
• UK Responsible Person
• Post-market Surveillance

End-to-end regulatory services for Eurasian Economic Union market compliance.

• EAEU Registration
• RZN Approval
• Technical Documentation
• Local Testing Support

Complete regulatory services for medical device registration in Switzerland.

• Swissmedic Registration
• CH-REP Services
• Medical Device Ordinance
• Market Surveillance

Regulatory pathway for medical devices entering the German market.

• BfArM Registration
• DIMDI Compliance
• Clinical Investigation
• Vigilance Reporting

Complete medical device registration services for French market.

• ANSM Registration
• UDI Implementation
• Clinical Evaluation
• Post-market Follow-up

Regulatory compliance services for medical devices in Italy.

• Ministry Registration
• Reimbursement Support
• Import Authorization
• Market Compliance

Complete regulatory pathway for medical devices in Spain.

• AEMPS Registration
• Technical Documentation
• Import Permits
• Quality Assurance

Regulatory services for medical device market entry in Netherlands.

• IGJ Registration
• Product Classification
• Import Licensing
• Compliance Monitoring