LlFESlL - SILICONE: INDUSTRIA E COMERCIO DE SILICONE, INSTRUMENTOS E MATERIAIS MEDICOS, CIRURGICOS E HOSPITATARES

Ensure the conformity of the devices in accordance with the QMS, before a device is released; Ensure that technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; Ensure that the post-market surveillance obligations are complied; Ensure reporting obligations are fulfilled; Ensure that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Ensure the conformity of the devices in accordance with the QMS, before a device is released; Ensure that technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; Ensure that the post-market surveillance obligations are complied; Ensure reporting obligations are fulfilled; Ensure that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.