Establishment of a quality management system according to ISO 13485:2021

Document Review according to MDR 745/2017 or IVDR 746/2017

Provision of external Person Responsible for Regulatory Compliance (PPRC) / Quality Management

Representative (QMR)

Provision of an authorised representative (EC-Rep) mandatory for manufacturers of medical devices /in-vitro diagnostic devices based outside the EU, with tasks such as:

Review of the issued EU Declaration of Conformity and the corresponding conformity assessment procedure

Review of the up-to-dateness of the technical documentation

Contact person for national authorities Review and advice on specific topics such as:

Risk Management | Clinical Evaluation |Usability

Software Lifecycle | Post Market Surveillance