Officers and regulatory representatives of P.I.H VARIA Sp. z o.o.
WITASZEK Jacek
Ensure conformity of devices in accordance with the Quality Management System (QMS) before release.
Keep the technical documentation and EU Declaration of Conformity up to date.
Oversee implementation of Post-Market Surveillance (PMS) activities.
Ensure compliance with vigilance and incident reporting requirements.
For investigational devices, ensure issuance of required regulatory statements.