Medical Device Packs

Technical Documentation

This package guides you through the process of setting up a technical file as required by tMDR PACK he MDR EU2017/745 Annex II/III

Quality Management System 

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

Person Responsible For Regulatory Requirements

Our PRRC service ensures that your organization PRRC art 15 is compliant with the MDR EU2017/7445 Art 15

Authorised Representative 

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