SHENYANG AERTI TECH CO.,LTD.

1.ensuring the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; 2.ensuring the post-market surveillance obligations are complied.

1.ensuring the reporting obligations referred to Vigilance are fulfilled.

1.ensuring the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 2.in the case of investigational devices, ensuring the statement referred to "the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject." is signed and issued.