Schwabe Pharma Italia

ensuring that: - 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); - in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

ensuring that: - 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; - the Declarations of Conformity of individual batches of medical devices are correctly drawn up and signed.

ensuring that: - the reporting obligations referred to in Articles 87 to 91 are fulfilled;