Jeil Medical Corporation

- Ensuring that 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. - Ensuring that the post-market surveillance obligations are complied with in accordance with Article 10(10) of the EU MDR. - Ensuring that the reporting obligations referred to in Articles 87 to 91 of the EU MDR are fulfilled.

-Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. -Ensuring that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the EU MDR is issued