Evondos Oy

Evondos products Quality and Regulatory Compliance. Evondos Quality Management System.

Vitacam related regulatory compliance: - main contact for Evondos Oulu; ensuring 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; ensuring the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; ensuring in case of investigational devices, the statement referred to in section 4.1 of chapter II of Annex XV is issued.

For Vitacam and Evondos Oulu: - ensuring the post-market surveillance obligations are complied in accordance with Article 10(10); ensuring the reporting obligations referred to in articles 87 to 91 are fulfilled