IntoCare Medical Technology (Suzhou) Co., Ltd.

a. the conformity of the device is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before device is released; b. in the case of investigational devices, issued a statement for the manufacture to conform the general safety and performance requirements apart from the aspects covered by the clinical investigation. c.In responsible for monitoring and management of EU regulation and guidelines, and to confirm the quality system update

a. Draw up and keep up-to-date technical documentation and the EU DoC; b. Post market surveillance obligations are complied with MDR Article 83; c. reporting obligations referred to MDR Articles 87 to 91 are fulfilled