ennoïa

(a) the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before release (b) the technical documentation and the EU DoC are drawn up and kept up-to-date (c) the PMS obligations are complied with in accordance with Article 10.10 (d) the reporting obligations referred to in Articles 87-91 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