Dirigeants et représentants réglementaires de Ephion
CLARAMUNT Mireia
Brief summary:
- the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released;
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- the PMS obligations are complied with;
- the reporting obligations are fulfilled;
- in the case of investigational devices, the statement referred to in Sect 4.1 (Chapt. II Annex XV) is issued.