Post-Market Surveillance for Medical Devices

 Post-Market Surveillance (PMS) of medical devices is a vital regulatory and quality function that ensures continued safety, performance, and real-world effectiveness after market entry. With evolving global regulations such as EU MDR and U.S. Food and Drug Administration post-market requirements, manufacturers must consistently monitor adverse events, analyze field data, and manage risks proactively. Freyr provides end-to-end post-market surveillance services, from complaint handling to PMSR/PSUR/PMCF reporting, helping organizations remain compliant, prevent recalls, and sustain market competitiveness.


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Why Post-Market Surveillance Matters in the Medical Device Lifecycle

Post-Market Surveillance (PMS) is a fundamental part of the medical device lifecycle, particularly under evolving regulations such as EU MDR, IVDR, and FDA post-market requirements. With the growth of SaMD, wearables, and connected technologies, continuous real-world monitoring and proactive risk identification are essential. Trends such as real-world evidence (RWE), digital vigilance, and patient-reported outcomes emphasize the importance of continuous safety and performance evaluation.

Manufacturers must integrate trend reporting, signal detection, and risk-based assessments into modern PMS systems. However, fragmented data, inconsistent reporting obligations, multilingual complaint channels, and heightened regulatory scrutiny create operational challenges. Preparing PMS Plans, PMSRs, PSURs, and PMCF documentation requires strong expertise and cross-functional collaboration.

Freyr delivers comprehensive PMS solutions aligned with global regulatory expectations. Our teams combine regulatory knowledge, structured processes, and multilingual support to optimize complaint handling, vigilance reporting, and PMS documentation. With experience across Class I–III, IVD, and SaMD devices, Freyr ensures high-quality reporting, timely compliance, and audit readiness.

Key Components of Post-Market Surveillance for Medical Devices

Effective PMS integrates multiple interconnected activities to monitor safety, performance, and emerging risks throughout a product’s lifecycle.

Complaint & Adverse Event Management

Systematic intake, investigation, and trending of complaints to identify safety signals and maintain compliance.

Vigilance & Reporting

Timely detection, assessment, and submission of adverse events and serious incidents to regulators.

Recalls, Corrections & Removals

Comprehensive management of field actions, including HHE, notifications, and effectiveness checks.

PMS Plan (PMSP)

A structured plan defining responsibilities, data sources, and evaluation methods.

PMSR, PSUR & PMCF

Mandatory reports summarizing post-market data and clinical follow-up activities.

Trend Reporting & Real-World Evidence

Analysis of real-world performance and complaint patterns to support preventive actions.

Freyr’s Post-Market Surveillance Services

Product Complaints Management

Device Recall, Corrections and Removals

PMSP, PMSR, PMCF, PSUR, Annual Maintenance

Health Hazard Evaluation

Medical Device Translation Services

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Why Partner with Freyr?

Extensive experience across FDA, EU MDR, IVDR, and APAC frameworks

End-to-end post-market lifecycle management

AI-enabled analytics and automated trending

Local-language regulatory specialists

Proven success in audit support and compliance excellence

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