a) the conformity of the devices is appropriately checked, in accordance with the quality management system, 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 (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled (e) in the case of investigational devices, the statement referred to Annex XV is issued.
Masqué
ARATA Valter
backup for a)conformity of the devices is appropriately checked, in accordance with the quality management system, 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 d) the reporting obligations referred to in Articles 87 to 91 are fulfilled e) in the case of investigational devices, the statement referred to Annex XV is issued.