ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA

conformity of the devices is appropriately checked, in accord. with the QMS under which the devices are manufactured, before a device is released the technical documentation and the EU DoC are drawn up and kept up-to-date the PMS 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