Acts as PRRC for:
- 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;
- The post-market surveillance obligations are complied with in accordance with Article 10(10);
- The reporting obligations referred to in Articles 87 to 91 are fulfilled.
Masqué
KOZOL Renana
Acts as PRRC for
- The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Masqué
Cartographie de TLV:PNAX
FabricantFabricant de systèmes ou nécessairesPersonnes