ensuring that:
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); (10(9) IVDR);
the reporting obligations referred to in Articles 87 to 91 are fulfilled; (82 to 86 IVDR).
Masqué
ROIG MONIQUE
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.