Officers and regulatory representatives of Abiogen Pharma S.p.A.
PORCHIA Francesca
MDR 2017/745 Art 15(3) (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-todate
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DE SUA Giovanna
MDR 2017/745 Art 15(3) (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; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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STICCA Romerai
MDR 2017/745 Art 15(3) (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