Dirigeants et représentants réglementaires de Biofaktor Sp. z o. o.
KONDEJ Karolina
Preparation of technical documentation and DoC
Verification of product conformity in accordance with QMS
Release for the market
Post-market surveillance
Preparation of reports and supervision of handling of serious incidents, external corrective actions and preventive actions
Acceptance and registration of incident reports
Conduct of investigations
Notification of the relevant supervisory authority and Notified Body
Archiving of documentation on major incidents and external corrective actions
Masqué
CENDROWSKA Iwona
ensuring that:
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before the device is released.
Masqué
Catalogue des dispositifs de Biofaktor Sp. z o. o.