Uromedica, Incorporated

Ensuring adequate resourcing of Uromedica’s QMS as it pertains to regulatory compliance activities; that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; that in the case of investigational devices, the statement referred to in EU MDR Section 4.1 of Chapter II of Annex XV is issued.

Ensuring that 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; that the post-market surveillance obligations are complied with in accordance with EU MDR Article 10(10); that the reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled.