SM ENG CO.,LTD.

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.