With the entry into force of EU MDR regulations, the client must adapt its quality system to meet nearly 1703 requirements, of which 891 are applicable. The mission consists in thoroughly analyzing existing documentation, identifying discrepancies and developing a compliance matrix. A detailed action plan is then drawn up and presented to the quality teams, with a clear distribution of roles between Apsalys and the client.

The regular review of the action plan, the implementation of dedicated SOPs in terms of labeling, clinical evaluation and usability, as well as the systematic review of the documents provided by client, makes it possible to monitor the evolution of compliance. This organized approach ensures not only strategic alignment with EU MDR requirements but also a continuous update of the gap assessment, thus offering a clear vision of the actions to be taken to achieve and maintain regulatory compliance.