Officers and regulatory representatives of FARMA-DERMA S.r.l.
MONTORSI Lorena
art. 15 (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(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;
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CORNIA Francesca
art. 15 (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
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BINO Alessia
art. 15 (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.