Dirigeants et représentants réglementaires de Evondos Oy
HAAVISTO Ville
Evondos products Quality and Regulatory Compliance.
Evondos Quality Management System.
Masqué
AHMAD Moyeen
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.
Masqué
KIRVESKOSKI Miikka
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