PMS and PMCF activities
We provide tailored Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) services to monitor device safety and performance after market entry. These activities are critical to maintaining regulatory compliance.
- Planning of PMS activities appropriate to the risk classification of the device
We develop PMS plans based on the device's risk classification, ensuring ongoing monitoring and compliance with regulatory requirements.
- Conducting proactive PMS, such as periodic literature review, vigilance database monitoring etc.
We actively conduct PMS activities, including literature reviews and monitoring of vigilance databases, to identify potential risks and maintain device safety post-market.
- Planning and conducting PMCF studies
We design and execute PMCF studies to gather additional clinical data post-market, ensuring continued safety and effectiveness of the device.
- Reporting of PMS activities, in PMSRs, PSURs, PMCFRs, and trend reports when necessary
We prepare and submit required PMS reports, including Periodic Safety Update Reports (PSURs) and Post-Market Clinical Follow-up Reports (PMCFRs), ensuring compliance with regulatory obligations.