Dirigeants et représentants réglementaires de KiOmed
THÉATRE Emilie
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.
Masqué
DESCHAMPS Audrey
- Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
- Ensuring that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Masqué
LENDERS Kevin
- Ensuring that the post-market surveillance obligations are complied with in accordance with Article 10(10).
- Ensuring that the reporting obligations referred to in Articles 87 to 91 are fulfilled.