Medical Device Packs

This MDR PACK guides you through the process of setting up a technical file as required by the MDR EU 2017/745 Annex II/III

This package guides you through the installation of a quality management system as required by the MDR EU 2017/745 Art 10.9 and ISO 13485

Our PRRC service ensures that your organization is compliant with the MDR EU 2017/745 Art 15

We can represent you as your EU representative (EC REP) as required by MDR EU2017/745 Art 11