Changzhou Sifary Medical Technology Co., Ltd.

1) the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; 2) organizing the technical documentation and the EU DOC are drawn up and kept up-to-date; 3) organizing the company to perform post-market surveillance obligations as required, and fulfilling reporting obligations; 4) ensuring the statement refered to in Section 4.1 of Chapter II of Annex XV is issued for investigational devices.