A-dec, Inc.

a)the conformity of the devices is appropriately checked, in accordance with the (QMS) under which the devices are manufactured, before a device is released;b) the tech doc and the EU DoC are drawn up and kept up-to-date;c) the post-market surv obligations are compiled in accordance with Art 10(10) of the MDR;d) the reporting obligations referred to in Art 87 to 91 are fulfilled;e) in the case of investigational devices, the statement referred to in Section 4.1 of Chpt II of Annex XV is issued.