ensuring that:
(a) 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;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
Masqué
KONDO Gen
ensuring that:
(a) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(b) the reporting obligations referred to in Articles 87 to 91 are fulfilled.