piur imaging GmbH

the technical documentation is drawn up and kept up-to-date; the post-market surveillance obligations are complied with in accordance with Article 10(10); the reporting obligations referred to in 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. (No investigational devices currently in scope; assignment held for future applicability)

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 EU declaration of conformity is drawn up and kept up-to-date;