i) the conformity of the devices is appropriately checked in accordance with the QMS under which the devices are manufactured, prior to release
ii) the technical files and the EU DoC are drawn up and kept up-to-date iii) the PMS obligations are complied with; iv) the reporting obligations referred to in Articles 87 to 91 are fulfilled; v) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Masqué
KIM Hyung Dong
i) the conformity of the devices is appropriately checked in accordance with the QMS under which the devices are manufactured, prior to release
ii) the technical files and the EU DoC are drawn up and kept up-to-date iii) the PMS obligations are complied with; iv) the reporting obligations referred to in Articles 87 to 91 are fulfilled; v) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.