Artificial Learning Systems India Private Limited

To check the conformity of the devices in accordance with the quality management system under which the devices are manufactured, before a device is released. Ensure all the regulatory requirements as expected by the regulatory body are implemented at Artelus • Identify all (regulatory requirements) basic safety standards (horizontal standards), group safety standards (semi-horizontal standards) and product safety standards (vertical standards) for Artelus products.

To check whether the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date for the products. To check whether the post-market surveillance obligations are complied with Article 10 (10) of the REGULATION (EU) 2017/745. To investigate whether the incident reporting obligations referred in article 87 to 91 of Regulation (EU) 2017/745 are fulfilled.