Officers and regulatory representatives of NeuroBell
NOONE Tara
Ensuring that:
(a) the conformity of the devices is appropriately checked before release;
(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;
(e) the statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigational devices.
Hidden
GIUFFRIDA Irene
Performing PRRC tasks in the absence of T. Noone
(a) ensuring pre-release device conformity checks are performed;
(b) ensuring technical documentation and the EU DoC are kept up-to-date;
(c) ensuring PMS obligations are complied with in accordance with Article 10(10);
(d) ensuring reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e) ensuring the statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigational devices