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Your EU-Rep Service

Reliable & Compliant 

Based in Austria, in the heart of Europe, we act as your official EU representative (EU Rep) in accordance with all relevant legal frameworks and regulations, ensuring that your medical devices meet all regulatory requirements for the European market.

We support your market access with a comprehensive range of regulatory services.

Your gateway to Europe

Our services

Dienstleistungen
EU-Rep Service

We act as your Representative in the European Economic Area and support you to get market access.

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EUDAMED Support

Registration with EUDAMED will soon be mandatory. We are happy to assist you in complying with the legal requirements.

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UDI
Support

To register your products in EUDAMED, you need a unique device identification (UDI) from an authorised issuing body. We can help you achieve compliance.

Audit Service

Our experienced auditors will be happy to check the compliance of importers or distributors on your behalf.

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External PRRC

We are happy to assume the role of responsible person for micro and small businesses, and ensure your regulatory compliance.

QM-
Support

Lost in a jungle of documents? We can help you create and maintain your streamlined QM documentation.​

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Would you like to know what's next?

We are constantly working to develop additional services to reduce and simplify the workload for everyone involved in the supply chain. Many of these services are already in the final stages of development and will be available to you shortly.

 

Contact us to be the first to benefit from the latest services.

Kontakt
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