Dirigeants et représentants réglementaires de MEDlight GmbH
LÄUBE Andreas
(a) checking of the conformity of the devices in accordance with the quality management system.
(b) drawing up / keeping up-to-date the technical documentation and the EU declaration of conformity.
(c) post-market surveillance obligations in accordance with Article 10(10).
(d) reporting obligations referred to in Articles 87 to 91.
(E) issuing the statement referred to in Section 4.1 of Chapter II of Annex XV in the case of investigational devices.