MedLaser Family Ltd.

the conformity of the devices was checked in accordance with the QMS used during the production and before the device was released; TFs and the EU DoC are drawn up and kept up-to-date; compilation of PMS obligations is done in accordance with Article 10(10); reporting obligations (Art. 87–91) in case of serious unexpected events and on-site safety corrective measures are fulfilled; in case of devices intended for clinical testing, statement referred to in Sec. 4.1 of Ch. II. of ANX. XV is issued