Dirigeants et représentants réglementaires de MED-EL
HERZOG Martin
The conformity of the devices is appropriately checked, in accordance, with the quality management system under which the devices are manufactured, before the device is released.
Masqué
GFOELLER Elizabeth
The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; and
in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued
Masqué
SIMONOTTI Laura
The post-marketing surveillance obligations are compiled in accordance with Article 10(10); and
the reporting obligations referred to in Articles 87 and 91 are fulfilled