Handling all EUDAMED Modules, Device Registrations, PMS, Vigilance.
All operations as per EU MDR 2017/745 Article 15 activities as
Device Conformity check as per implemented QMS before its release.
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).
The reporting obligations referred to in Articles 87 to 91 are fulfilled.
Masqué
AMEEN Ali
Handling all EUDAMED Modules, Device Registrations, PMS, Vigilance.
All operations as per EU MDR 2017/745 Article 15 activities as
Device Conformity check as per implemented QMS before its release.
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).
The reporting obligations referred to in Articles 87 to 91 are fulfilled.