MEDICAL DEVICES VIGILANCE
AENORASIS S.A. applies and maintains a medical devices vigilance system in order to safeguard the responsibilities and obligations with regards to all medical devices that we distribute as an exclusive distributor.
The main objective of the medical devices vigilance system is to continuously improve health and safety protection of the patients and of the users, by constant monitoring in order to reduce the risk of a case to occur/ re-occur.
AENORASIS S.A. makes good use and assesses the reported cases, the bibliography and the available information in order to prevent occurrence/ re-occurrence of cases or/and to limit and control possible consequences.
In this framework AENORASIS S.A. additionally:
- Has an in-house Qualified Person on Medical Devices Vigilance (QP MDV) who is adequately trained and has a documented experience on all aspects of Medical Devices Vigilance
- Organizes regular training programs on medical devices vigilance for the company’s HR.
- Sees to an effective and functional communication with the Pharmaceutical Authorities, with Health Professionals and with patients in order to receive reports on adverse reactions.
- Has a regular communication with all control and production networks of the companies we represent and with official bodies in Greece, in order to acquire direct and valid information on the pharmaceutical products we offer.
You may contact us on any issue concerning a medical device we distribute in one of the following ways:
Contact Our Quality Assurance Department
+30 210 6136332
