SPINE INNOVATIONS

All

Substitute for : (a) | 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; b) | the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) | the post-market surveillance obligations are complied with in accordance with Article 10(10);c (d) | the reporting obligations referred to in Articles 87 to 91 are fulfilled;

Substitute for art 15: (b) | the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (d) | the reporting obligations referred to in Articles 87 to 91 are fulfilled;