Post-Market Surveillance

Stay ahead of global Regulatory demands with Freyr’s comprehensive Post-Market Surveillance (PMS) services for medical devices. From FDA medical device complaint handling to EU MDR post-market surveillance requirements, our experts deliver end-to-end support, so you can stay on top of medical device regulatory compliance.

Post-Market Surveillance Overview

Post-market surveillance (PMS) is essential for medical device manufacturers and other firms involved in distribution of devices to ensure patient safety, medical device regulatory compliance, continuous product improvement and ensuring that medical devices remain safe, effective and compliant after they enter the market.

Freyr’s post-market surveillance consultants help medical device manufacturers navigate the complexities of post-market surveillance regulations, including EU MDR post-market surveillance requirements and FDA medical device complaint handling.

Post-Market Surveillance Services

  • Products Complaints management


    End-to-end complaints management from intake to reporting and closure, ensuring efficient, effective, and timely closure of complaints as part of robust medical device PMS processes.

  • Device Recall & Return Management


    Our team of experts will assist you in navigating complex regulations related to medical device recall and field safety actions, ensuring compliance, efficiency, and minimum disruption.

  • Corrections and Removals


    Our team will help with risk assessment, communication to regulatory authorities and customers and ensure compliant documentation.

  • PMSP, PMSR, PMCF, PSUR, Annual Maintenance


    Comprehensive support in creating, updating, and maintaining PMS documentation, including PMS Plans, PMS Reports, PMCF services, PSURs, and annual regulatory updates through expert post-market surveillance for medical devices.

  • Multi-channel and multi-lingual contact center support


    Our dedicated local affiliates in multiple countries across the world, will enable cost-effective and timely support enhancing customer service.

  • Medical inquiry and response


    Acting as an interface between the MAH and the patient or consumer our team will ensure consistent and controlled responses to the inquiries, forming an essential part of post-market surveillance.

  • Health Hazard Evaluation


    We conduct scientific, evidence-based evaluations to assess the severity and probability of harm resulting from product issues, forming the basis for regulatory communication and decision-making around recalls or FSCA.

  • Medical Device Translation Service


    Accurate, regulation-compliant translation of all PMS-related documentation including complaints, customer communication, FSNs, patient information, IFUs, labels, and regulatory reports delivered by native speakers with domain expertise.

Celebrating Customer Success

Why Partner with Freyr?