Officers and regulatory representatives of SVAS BIOSANA
FERRANDINO Carla
conformity of the devices is appropriately checked,in accordance with the QMS under which the devices are manufactured, before a device is released;the TD and the EU DoC are drawn up and kept up-to-date; the post-market surveillance obligations are complied with in accordance with Article 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.