Officers and regulatory representatives of MAROL BIS SP. Z O. O.
OLCZAK Łukasz
Ensure conformity of devices in accordance with the Quality Management System (QMS).
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.