Your Expert for Regulatory Compliance in the EU.

In the dynamic world of medical device regulation in the European Union, the role of the Person Responsible for Regulatory Compliance (PRRC) is indispensable. At MEDAGENT, we offer a comprehensive PRRC service to ensure that your products meet the latest EU regulations.

Our PRRC Services

With experience from conducting more than 200 audits per year, we continuously monitor compliance with EU regulations for medical devices and in vitro diagnostics (IVD).

Our team provides detailed advice on the EU MDR (Medical Device Regulation) and EU IVDR (In vitro Diagnostic Medical Devices Regulation).

We assist in the creation, review, and maintenance of the necessary technical documentation and reporting.

Why Choose MEDAGENT as Your PRRC Partner?

With in-depth knowledge and practical experience from over 200 audits annually, our experts are always up-to-date with EU legislation.

We ensure that your products meet the highest compliance standards, thereby minimizing the risk of non-compliance.

Whether for a startup or an established company, we offer customized solutions for your specific needs.

BildLogo e1699903904709

Contact us

Let’s work together to ensure worry-free compliance and smooth market access in the EU. For more information about our PRRC service or to avail of it, contact us. We are here to support you at every step of regulatory compliance.

Contact Responsible Person