Pharmacovigilance and vigilance of medical devices
Pharmacovigilance services include:
- a local pharmacovigilance contact with 24-hour availability,
- collecting and reporting suspected adverse events and other safety information,
- maintaining the pharmacovigilance system,
- preparing and maintaining standard operating procedures (SOPs),
- communication with the competent authority and our partners,
- reviewing nationally prescribed literature,
- monitoring of local legislation and HA website,
- preparation of applications for review of educational material (under the RMP) and preparation of DHPCs.
As part of our medical device vigilance services, we provide:
- local contact with 24-hour standby,
- communication with the competent authority (reporting to the competent authority about incidents with medical devices)
- informing customers in case of field safety notices and incidents with medical devices.