CapsoVision, Inc.

a) the conformity of the devices in accordance with the quality management system under which the devices are manufactured before released; b) the technical documentation and the EU declaration of conformity are drawn up and up-to-date; c) the post-market surveillance obligations are complied with MDR d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; e) in the case of investigational devices, the statement referred in Section 4.1 of Chapter II in Annex XV is issued.