Terumo (Philippines) Corporation

- 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. - the post-market surveillance obligations are complied with in accordance with Article 10 (10) - the reporting obligations referred in MDR Article 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.

- ensuring that Technical Documentation and the EU Declaration of Conformity are drawn up and kept up to date