Ion Beam Applications S.A.

ensuring that (a) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (b) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

for ensuring that (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 post-market surveillance obligations are complied with in accordance with Article 10(10); (c) the reporting obligations referred to Articles 87 to 91 are fulfilled.

ensuring that (a) the conformity of the devices is checked, in accordance with the QMS under which the devices are manufactured, before its release; (b) the TD and the EU DoC are drawn up and kept up-to-date; (c) the PMS obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.