Outsourcing

Man and Woman in Office Smiling

We handle your regulatory and administrative tasks efficiently, compliantly, and cost-effectively – e.g., as legal manufacturer in the EU or US agent

Sit back, relax, and leave it to us to take on the responsibility for your regulatory compliance in new markets, the establishment and continuity of your quality management system, or the entire initial approval process for your medical device in Europe.

Authorization/Regulatory Roles

Our team ensures successful expansion into new markets – as PRRC, authorized representative, or in other regulatory roles. 

 

Legal Manufacturer EU

We are your legal manufacturer and take full regulatory responsibility for your medical devices in Europe. 

 

We are always there for our customers

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