AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

(a) the conformity of the devices is in accordance with the QMS under which the devices are manufactured, before a device is released; (b) the TD and the EU DOC are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with <Post Market Surveillance Procedure>; (d) the reporting obligations referred to in <Vigilance System Control Procedure> are fulfilled. (e) investigational devices, see Chapter II of Annex XV.

(a) the conformity of the devices is in accordance with the QMS under which the devices are manufactured, before a device is released; (b) the TD and the EU DOC are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with <Post Market Surveillance Procedure>; (d) the reporting obligations referred to in <Vigilance System Control Procedure> are fulfilled. (e) investigational devices, see Chapter II of Annex XV.