Entegrion, Inc.

a) The conformity of 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 with in accordance to Article 10(9); d) The reporting obligations referred to in Articles 82 to 86 are fulfilled [vigilance];