Post-Market Surveillance & Post-Market Clinical Follow-Up
We are committed to supporting our clients in all aspects of Post-Market Surveillance (PMS), ensuring the preparation and maintenance of comprehensive PMS documentation is seamless and stress-free.
Cost-efficient
Due to a highly streamlined preparation process and high report volume in PMS reports and PSURs, we can provide report creation services at very competitive price.
Automated
Explore "Spectrum", our medical device regulatory app platform to manage your device portfolio and prepare and maintain complex PMS documentation with a single click.
Clean
Retrieve appealing, well-formatted, clean output documents that are free of barriers and contain active links to identified literature and event reports for seamless document navigation.
PMS plan
Manufacturers are required to establish a comprehensive PMS plan that outlines how they will systematically collect and analyze data related to device performance, adverse events, and other relevant information. The plan should cover how the manufacturer will proactively monitor the device's safety and performance throughout its lifecycle.
PMS report
Turn data into actionable insights with our PMS Report Service. We'll compile and analyze your PMS data, generating comprehensive reports that allow you to proactively monitor and improve device safety and performance.
Regular PMS service
Stay ahead in regulatory compliance with our Post-Market Regular Update Plan. This all-inclusive service handles the creation and maintenance of all essential PMS documents, including PMS plans, PMCF evaluation plans / reports, PMS reports, and PSURs. Focus on your core competencies while we ensure your ongoing compliance with industry standards.
PMS plan
PMCF evaluation plan / report
PMS report / PSUR