HARDIK INTERNATIONAL PRIVATE LIMITED

1. Appropriate check of the conformity of the devices in accordance with the quality management system under which such devices are manufactured and before such devices are released. 2. Drawing up and keeping up to date of the technical documentation and the EU declaration of conformity of devices. 3. Fulfillment of the post-market surveillance obligations in accordance with Article 10(10). 4. Fulfillment of Vigilance reporting obligations referred to in Articles 87 to 91.