Medicom SAS

Technical documentation and the EU DoC are drawn up and kept up-to-date. PMS obligations are complied with in accordance with Art.10. Reporting obligations referred to in Art. 87 to 91 are fulfilled. In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. Conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.