Embedded Files
Technical Documentation
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
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
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
Authorised Representative
We can represent you as your EU representative (EC REP) as required by MDR EU2017/745 Art 11
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