Health Beacons

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) [MDR] d) the reporting obligations referred to in Articles 87 to 91 [MDR] with regard to PMS reporting, are fulfilled;