Aeffe Farmaceutici S.r.l.

a) the conformity of the devices in accordance with the quality management system, before a device is released; b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; c) the PMS obligations are complied with in accordance with Article 10(10); d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; e) in the case of investigational devices, the statement referred to in n Section 4.1 of Chapter II of Annex XV is issued

a) the conformity of the devices in accordance with the quality management system, before a device is released; b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; c) the post-market surveillance obligations are complied with in accordance with Article 10(10); d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;