Hindustan Syringes & Medical Devices Ltd.

(a) Ensuring that, the conformity of the devices in accordance with the Quality Management System before a device is released. (b) Ensuring that, the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. (c) Ensuring that, the post-market surveillance obligations are complied with in accordance with Article 10(10). (d) Ensuring that, the reporting obligations referred to in Articles 87 to 91 are fulfilled.

a) 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; b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; c) the post-market surveillance obligations are complied; d) vigilance reporting obligations are fulfilled;