Clinical Investigations

Post-market Investigations

Post-market investigations are an integral part of continuous surveillance on medical devices and are crucial for identifying any safety or performance issues that may arise after the approval and market introduction of a medical device.

The main focus of the project is to provide comprehensive support for devices already on the market, focusing on post-market surveillance or the generation of scientific evidence to support the devices.

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THE PROJECT

Services Offered by the Project

Continuous Monitoring: After the device has been marketed, continuous monitoring is initiated to promptly identify any safety issues or unforeseen side effects.

Post-Marketing Data Collection: Additional data on the device’s use by patients and physicians is collected. This data can be used to assess long-term effectiveness and safety.

Adverse Event Reporting: Physicians and patients are encouraged to report any adverse events or issues related to the medical device. These reports are important for promptly identifying potential risks.

Updates and Enhancements: Based on post-marketing data and feedback, the device may undergo improvements or updates to ensure continued safety and effectiveness.

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