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
HESSABI Lisa
Technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
Masqué
HOPPE Nicole
Post-market surveillance obligations are complied with in accordance with Article 10(10).
Reporting obligations referred to in Articles 87 to 91 are fulfilled.