Committed to supporting medical device manufacturers in achieving full EU regulatory compliance and seamless market access.
Medical Device Compliance
01
Ensuring patient safety and product quality through robust MDR & IVDR compliance services.
Regulatory Safety
02
Leveraging our expertise to provide comprehensive guidance, inspection readiness, and post-market surveillance support.
Regulatory Solutions
03
About Us
We are a specialized regulatory compliance partner providing European Authorized Representative (EAR) services for medical device manufacturers and importers seeking access to the European market.
With deep expertise in EU MDR (2017/745) and IVDR (2017/746), we support non-EU companies in meeting their legal obligations and maintaining continuous compliance throughout the product lifecycle. Acting as the official link between manufacturers and EU competent authorities, we ensure transparency, readiness, and regulatory confidence.
Our multidisciplinary team combines regulatory affairs professionals, quality and compliance experts, and specialised legal advisors to deliver reliable, inspection-ready solutions. From EUDAMED registration and technical documentation management to post-market surveillance and vigilance support, we help our partners operate securely and build long-term credibility in the European healthcare market.
Achieve EU Compliance
With Confidence
EUDAMED Registration
Full registration of manufacturers and medical devices according to EU MDR & IVDR standards.
Secure Documentation Management
Verification and safe storage of EU Declarations of Conformity and technical files for 10 years.
Post-Market Compliance Support
Monitoring, vigilance, and incident reporting to ensure ongoing EU.
Regulatory-Compliant Product Testing
Execution or coordination of medical device testing according to EU MDR, IVDR, and harmonized standards.
EAR Labeling & Documentation
Inclusion of European Authorized Representative details on product labels and regulatory documents.
Post-Market Compliance Support
Monitoring, vigilance, and incident reporting to ensure ongoing EU MDR & IVDR compliance.
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