Suzhou Hokapi Biomedical Engineering Co., Ltd..

1) the TD and the EU DOC are drawn up and kept up-to-date; 2) the PMS obligations are complied; 3) the reporting obligations are fulfilled; 4) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects; 5)the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released;