Lunit International Limited

Ensures ongoing effectiveness of QMS. Confirms adherence to MDR requirements. Ensures a Post-Market Surveillance system is established. Ensures reporting procedures are established.

Checks the conformity of the devices is in accordance with the QMS under which the devices are manufactured, before a device is released. Establishes and keeps up to date the technical documentation and the EU declaration of conformity. Ensures the post-market surveillance obligations are complied with in accordance with Article 10(10). In accordance with defined procedures, maintains PMS/CF, and CE Plans and Reports. Ensures the reporting obligations referred to in Art. 87 to 91are fulfilled.