Officers and regulatory representatives of S.A.L.F.
SCAFATI Marco
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.
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IPPOLITO Marina
Article 15 - (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
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MARINI Silvia
Article 15 -
(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;
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.