Authorized Representative Service -
Raising Success to New Heights
Lumis International - Your Seamless Entry to the EU Market
Are you a medical device manufacturer located outside the European Union?
Lumis International is your gateway to the European market through our authorized representative service.
We help you navigate all complex compliance processes, ensuring you meet the stringent requirements of the MDR and IVDR.
Let Lumis be your partner in accessing new markets.
The Benefits of Choosing Lumis as Your Authorized Representative
Enter Europe With Confidence
Our approach is transparent, detailed and streamlined to ensure swift, compliant access to the EU market.
During an initial review, our team assesses your manufacturer’s regulatory, quality, legal and technical documentation.
Following enrollment, Lumis will store the necessary documentation, support with vigilance reporting, review any amended documents, communicate with authorities and conduct any other activities outlined in the mandate.
The Process
Contact us to find out more!