
MEDICAL DEVICE VIGILANCE
- SOP creation and maintenance
- Incident processing and reporting
- Literature screening
- Periodic Vigilance Reports
- Field Safety Corrective Actions
- EUDAMED registration and maintenance
- Safety database
- Medical device clinical investigation safety
- PMS studies
For more information please contact
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Heta Karvinen
MSc (Chemistry)
Director, Pharma Regulatory Affairs
heta.karvinen@medfiles.eu
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Satu Kujala
Head of Pharmacovigilance, EU QPPV
satu.kujala@medfiles.eu