Laboratorios Salvat, S.A.

The conformity of the devices is appropriately checked in accordance with the QMS under which the devices are manufactured before a device is released. The technical doc and the EU DOC are drawn up and kept up-to-date. The post-market surveillance obligations are complied with in accordance with Art10(10). The reporting obligations referred to in Art87 to 91 are fulfilled. In case of investigational devices the statement referred to in Section 4.1 of Chapter II of Annex XV is issued