check the conformity of the devices based on the quality management system under which the devices are manufactured, before a device is released; draw up and keep-up-to-date the technical documentation and the EU declaration of conformity; ensure the post-market surveillance obligations in accordance with Art. 10(10); ensure the reporting obligations referred to in Art. 87 to 91; in the case of investigational devices, to issue the statement referred to in Section 4.1 of Chapter II of Ann. XV.
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CICCIONE Alessia
check the conformity of the devices based on the quality management system under which the devices are manufactured, before a device is released; draw up and keep-up-to-date the technical documentation and the EU declaration of conformity; ensure the post-market surveillance obligations in accordance with Art. 10(10); ensure the reporting obligations referred to in Art. 87 to 91; in the case of investigational devices, to issue the statement referred to in Section 4.1 of Chapter II of Ann. XV.