Once regulatory approval has been obtained to market a medical device, the post-market activities commence in earnest. To ensure continuous monitoring of your device in clinical use, specifically relating to safety, performance and efficacy, the following systems are required depending on the classification of your device:

• Safety and vigilance/medical device reporting for both clinical and commercial devices.
• Post-Market Surveillance planning and reporting.
• Post-Market Clinical Follow Up planning and reporting.
• Periodic Safety Update Reports.
• Recall systems and reports.
• Summary of Safety and Clinical Performance.

We can assist you in determining if clinical experiences associated with your device must be reported to the appropriate regulatory authorities and complete the appropriate forms. Our post market reports for all classes of devices across many medical areas are continuously reviewed and accepted by many regulatory authorities.