Beijing Microkpro Medical Instrument Co., Ltd.

a)check the conformity of the devices in accordance with the quality management system under which the devices are manufactured before a device is released; b)draw up and keep up-to-date the technical documentation and the EU declaration of conformity; c)fulfil the post-market surveillance in accordance with Article 10(10); d)fulfil the reporting obligations referred to in Articles 87 to 91; e)issue the statement referred to in Sec 4.1 of Chapter II of Annex XV for investigational devices.