Our Post-Market Surveillance service helps medical device manufacturers maintain compliance and monitor device performance after launch. We track adverse events, analyze recall trends, and assess real-world performance to support ongoing safety monitoring and regulatory compliance.
How our post-market surveillance service delivers value to your organization.
Real-time monitoring of adverse event reports from FDA MAUDE, global vigilance databases, and other sources.
Tracking and analysis of device recalls with root cause identification and preventive action recommendations.
Real-world device performance assessment using registry data, claims data, and post-market studies.
Support for post-market surveillance regulatory requirements including PMCF studies and vigilance reporting.
Comprehensive deliverables that provide actionable intelligence for your team.
A structured methodology that delivers results in four phases.
Develop comprehensive post-market surveillance plan aligned with regulatory requirements.
Set up monitoring systems for adverse events, recalls, and real-world performance data.
Analyze surveillance data to identify safety signals, performance trends, and compliance gaps.
Deliver regular surveillance reports with recommendations for corrective and preventive actions.
We monitor FDA MAUDE, MedWatch, global vigilance databases (EU EUDAMED, UK MHRA), device registries, claims data, and social media for patient-reported adverse events.
Yes, we support EU MDR post-market surveillance requirements including PMCF studies, PSUR preparation, and vigilance reporting.
We provide real-time alerts for serious adverse events and device recalls, with detailed analysis reports delivered within 48 hours.
Navigate FDA 510(k), PMA, De Novo, and CE marking pathways with clear regulatory strategy and submission planning.
Learn moreClinical trial design and evidence generation strategy tailored to regulatory requirements and payer expectations.
Learn moreComprehensive competitive landscape analysis with feature comparison, pricing benchmarks, and market share assessment.
Learn moreConnect with our team to discuss how our post-market surveillance service can support your goals.
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