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.
Masqué
RIDA Yamina
- 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;