Officers and regulatory representatives of DERMOSCIENCES FRANCE
MTEIREK Rana
LAA-
Actor module management and update EUDAMED-
Clinical investigation-
UDI registration (as PRRC backup)-
Vigilance andpost-market surveillance (as PRRC backup)-
the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
Post-market surveillance obligations are complied with in accordance with Article 10(10) of MDR 2017/745 regulation.
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DERMIGNY Megane
LUA-
UDI registration-
Vigilance and post-market surveillance notification.-
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 reporting obligations referred to in Articles 87 to 91 are fulfilled;