Officers and regulatory representatives of Decumed ApS
ROSSING Laura
The conformity of the devices are checked in accordance with the QMS before a device is released
The technical documentation and the EU declaration of Conformity are drawn up and kept up to date
The post-marketing surveillance obligations are compiled within acordance with article 10(10)
The reporting obligations referred to in Articles 87 to 91 are fulfilled
In case of investigational devices, the statement referred to in section 4.1 of chapter II of Annex XV is issued