Officers and regulatory representatives of PHOENIX S.R.L.
PRANDINI Federico
ensuring that:
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- the post-market surveillance obligations are complied with in accordance with Article 10(10) of MDR;
- the reporting obligations referred to in Articles 87 to 91 of MDR are fulfilled;
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of MDR is issued.
Hidden
PIVA Annarosa
ensuring that:
- 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;