Why choose us
- Ensure compliance with EU MDR 2017/745 and IVDR 2017/746
- Navigate European market access with confidence
- Full regulatory support for EU market entry
EU Representative
Your trusted EU Representative for medical devices
Sell in Europe with confidence. We act as your Authorized Representative under EU MDR and IVDR.
Certified support
Services offered
- Acting as your EU Authorized Representative
- Ensuring compliance with European regulatory requirements
- Managing post-market surveillance and vigilance for your devices
- Preparation of EU Declaration of Conformity
How we work with you
Consult
We review your business and goals.
Prepare
We close gaps in documents and processes.
Audit
We guide you through your assessment.
Certify
You get your certificate and ongoing support.