ALLCARE INNOVATIONS

- 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; - the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; - the post-market surveillance obligations; - the reporting obligations are fulfilled; - in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.