Our EU MDR & Global Regulatory Services
EU MDR Strategy & Compliance
End-to-end support to achieve and maintain EU MDR compliance.
EUDAMED Registration & Support
Actor registration, UDI/device registration, and certificate management.
Technical Documentation
Prepare and review technical documentation in accordance with EU MDR requirements.
Clinical Evaluation & PMS
Clinical evaluation reports and post-market surveillance (PMS) support.
International Registrations
Product registrations and market access support in 85+ countries worldwide.
Authorized Representative & Local Support
AR services and local regulatory support for international markets.
Global Reach. Local Expertise.
Supporting medical device companies with regulatory registrations and market access in over 85 countries across North America, South America, Europe, Middle East, Africa, and Asia Pacific.
International Product
Registrations
Our Global Regulatory Process
- 1
Assess & Plan
Understand your device, target markets, and regulatory pathway.
- 2
Regulatory Strategy
Develop a customized strategy for compliance and registrations.
- 3
Documentation Preparation
Prepare technical files, clinical evaluation, and supporting documents.
- 4
Submissions & Registrations
Submit and manage registrations and regulatory submissions.
- 5
Compliance & Maintenance
Support ongoing compliance, renewals, and change management.
- 6
Market Access Support
Provide guidance for market access and local country requirements.
EU MDR Expertise
Full support for compliance with EU MDR 2017/745
EUDAMED Support
Actor, UDI/Device registration and certificate management
85+ Countries
Successful registrations worldwide
Global Standards
ISO 13485, MDSAP, and regional requirements
End-to-End Support
From strategy to registration and post-market support
Proven Results
Helping clients achieve compliance and access