ACTEON MANUFACTURING

(a) the conformity of the devices is appropriately checked, in accordance with the QMS before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations cf Article 10(10); (d) the reporting obligations cf Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date (Back-up) (c) the post-market surveillance obligations cf Article 10(10); (Back-up)

(a) the conformity of the devices is appropriately checked, in accordance with the QMS before a device is released; (back-up)

(d) the reporting obligations cf Articles 87 to 91 are fulfilled; (back-up)

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date (Back-up) (c) the post-market surveillance obligations cf Article 10(10); (Back-up)

Materiovigilance