Critical Diagnostics

Ensuring all elements of Article 15 are met, including: -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 DoC are drawn up and kept up-to-date; -the post-market surveillance obligations are complied with in accordance with Article 10(9); -the reporting obligations referred to in Articles 82 to 86 are fulfilled;