Authorized Represen­tative Services & Regulatory Roles

Handshake in a Business Context

Successful expansion into new markets: With us at your side, your global regulatory compliance is ensured

We help you to quickly and success­fully launch your medical and IVD medical devices in new markets. We support you with our professional authorized represen­tative services and by taking on relevant regulatory roles in navigating complex local legislation and standards.

In-country Representation

We are your reliable authorized repre​​​​​sen­tative in Europe and Switzerland, as well as your Responsible Person in the United Kingdom, and your US Agent in the USA, ensuring your ​​​​​​​successful market access. 

 

QMR

As your experienced external quality management representative (QMR), we ensure regulatory compliance of your quality management system. 

 

PRRC

We take on the role of the Person Responsible for Regulatory Compliance (PRRC) according to MDR and IVDR and ensure your regulatory compliance. 

 

We are always there for our customers

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