Medical device vigilance is the monitoring of the safety profile of medical devices, from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action. This to ensure that patient’s and healthcare professional’s safety is monitored and action taken as soon as a safety concern with a medical device arises. Manufacturers are obliged to maintain robust medical device vigilance and post marketing surveillance systems in order to attain and maintain their CE certificate.
Here at Panacea, we provide a wide and varied range of Medical Device Vigilance services, including:
- Review of medical device vigilance processes with feedback on processes and standard operating procedures.
- Incident management and reporting
- Field Safety Corrective Action management
- Field Safety Notice drafting
- Product reconciliation coordination
- Expedited Reporting to Authorities
- Coordination of investigations and reporting to regulatory authorities
- Input into Post Marketing Surveillance