Galena Pharma has a post-market surveillance system (PMS) for medical devices audited by a notified body.
The safety system enables us to perform continuous assessments of the risk-benefit ratio of medical devices that are under development or already on the market. If necessary, we take appropriate measures to safeguard public health.
The PMS system allows us to act on behalf of the client as a legal manufacturer of a medical device.
OUR SERVICES INCLUDE:
- Acting as a Person Responsible for Regulatory Compliance (PRRC) of medical devices
- Compiling and updating Periodic Safety Update Reports (PSURs), Clinical Assessment Reports (CERs), PMS, and Post-Market Clinical Follow-up (PMCF) plans and reports
- Handling adverse events and hazards
- Exporting product information to the Eudamed database
- Electronic reporting of adverse reactions and events to the Eudamed database
- Translating medical device safety documentation
- Performing literature follow-up for medical devices
- Managing safety signal detection and evaluation processes
- Performing risk management and risk minimization measures
For more information, contact our expert or fill the contact form.