Buona Spa Società Benefit

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.

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.