W.H.P.M. Bioresearch & Technology Co., Ltd.

(1) 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; (2) the post-market surveillance obligations are complied with in accordance with IVDR Article 10(9); (3) the reporting obligations referred to in IVDR Articles 82 to 86 are fulfilled;

in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in IVDR Section 4.1 of Annex XIV is issued.

the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;