Endospan Ltd

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 PMS obligations are complied with in accordance with Article10 d the reporting obligations referred to in Articles 87-91 e in the case of investigational devices statement ref in Sec 4.1 Cp II of Ann XV

- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; - the post-market surveillance obligations are complied with in accordance with Article 10(10); - the reporting obligations referred to in Articles 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