HigoSense Sp. z o.o.

MDR 2017/745, art.15; Ensuring that: 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 with in accordance with Article 10(10); d) the reporting obligations referred to in Articles 87 to 91 are fulfilled.