CADskills BV

- the technical documentation and the EU declaration of conformity are drawn up and kept up to date. - the post-market surveillance obligations are complied with in accordance with MDR Article 10(10). - the reporting obligations referred to in MDR Articles 87 to 91 are fulfilled. - in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

- 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.