conformity of the devices is appropriately checked, under the QMS under which devices are manufactured before they are released; technical documentation and EU DoC are drawn up and kept up-to-date; the post-market surveillance obligations complies with Regulation (EU) 2017/745 Art.10(10); the reporting obligations referred to in the Regulation Art.87-91 are fulfilled; in the case of investigational devices, the statement referred to in Sec.4.1 of Chapter II Annex XV of the Regulation is issued
Masqué
KIM Ye Ji
conformity of the devices is appropriately checked, under the QMS under which devices are manufactured before they are released; technical documentation and EU DoC are drawn up and kept up-to-date; the post-market surveillance obligations complies with Regulation (EU) 2017/745 Art.10(10); the reporting obligations referred to in the Regulation Art.87-91 are fulfilled; in the case of investigational devices, the statement referred to in Sec.4.1 of Chapter II Annex XV of the Regulation is issued