Officers and regulatory representatives of APEX ES SPECIALISTS, S.L.
DU Haohua
The conformity of the devices is appropriately checked in accordance with the quality management system;
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);
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.