MEDICA SUD INDUSTRIE DISPOSITIFS MEDICAUX

Ensuring that: -The 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 -The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; -The post-market surveillance obligations are complied with in accordance with Article 10(10);

Ensuring that: -The reporting obligations referred to in Articles 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.