Officers and regulatory representatives of Planmeca Oy
VUORIKALLAS Niina
- Quality management system
- EU declaration of conformity
- Vigilance reporting
Hidden
KANERVA Jukka
CAD/CAM devices:
- conformity of devices
- technical documentation
- post market surveillance
- reporting obligations related to vigilance
- conformity of investigational devices
Custom-made devices: Promodel service
- Overall responsibility (not shared)
Hidden
PUHLIN-NURMINEN Helianna
Digital devices (software as a medical device):
- conformity of devices
- technical documentation
- post market surveillance
- reporting obligations related to vigilance
- conformity of investigational devices
Hidden
MULLER Timo
Dental x-ray devices:
- conformity of devices
- technical documentation
- post market surveillance
- reporting obligations related to vigilance
- conformity of investigational devices
Hidden
JURVANEN Tuomas
Dental units:
- conformity of devices
- technical documentation
- post market surveillance
- reporting obligations related to vigilance
- conformity of investigational devices