Post-Market Surveillance Services

Post-market surveillance (PMS) plays an integral role in ensuring that medical devices continue to meet safety, performance, and regulatory compliance requirements after they have entered the market. Global regulatory bodies like the FDA, European Medicines Agency (EMA), and others have stringent expectations for manufacturers to monitor devices in real-world use. Manufacturers are required to detect potential issues early and report adverse events to ensure that any risks are mitigated.

Our PMS services are tailored to help manufacturers design, implement, and maintain effective surveillance systems. These systems are customized according to the device's risk profile and the specific regulatory requirements in the regions where the device is marketed. For high-risk devices, regulations such as the EU MDR mandate ongoing post-market clinical follow-up (PMCF) to continuously monitor the device's safety and performance. We help with planning and executing PMCF activities to ensure compliance with these regulations.

In the United States, manufacturers of high-risk devices are often required to conduct post-approval studies as part of their PMS strategy. Our team provides comprehensive support throughout the study process, including study design, data analysis, and reporting. By guiding manufacturers through post-approval requirements, we help ensure continued compliance with FDA regulations and that any potential risks associated with devices are managed promptly.

Our PMS services extend beyond just meeting reporting obligations. We offer continuous monitoring of real-world data, including adverse event reports, field safety corrective actions (FSCAs), and recalls. These activities help identify trends that could affect the safety and performance of devices. For manufacturers selling devices globally, our team ensures that your surveillance programs meet the varied requirements of regulatory authorities in different regions, such as Periodic Safety Update Reports (PSURs) required under the EU MDR.

Additionally, we support manufacturers in responding to adverse event follow-up requests and deficiency letters from regulatory agencies. By maintaining an active PMS program, manufacturers can ensure their devices remain safe, effective, and compliant over time. With our expertise, we help companies streamline their post-market surveillance processes, providing real-time insight and data analysis to ensure regulatory compliance and patient safety. Whether preparing for audits or responding to adverse events, we are here to help you maintain compliance in an ever-evolving regulatory environment.

Our post-market surveillance services include:

• Recall Management and Communication: Minimize disruption and maintain regulatory compliance by effectively managing and communicating recalls.
• Labeling and Instructions for Use (IFU): Ensure your device labeling and IFU remain accurate and compliant with current regulations.
• Advertising and Promotion Compliance: Stay ahead of regulatory changes to ensure your advertising and promotional materials align with industry standards.
• PMS Reports and PSURs: Meet global reporting obligations by submitting periodic reports that reflect ongoing device performance.
• Post-market Clinical Follow-Up (PMCF): Strengthen product safety and effectiveness with ongoing clinical evaluations to support regulatory requirements.
• Post-market Performance Follow-Up (PMPF): For in vitro diagnostic devices (to comply with Part B of the new IVDR Annex XIII), ensure you continuously monitor performance to ensure that your device reflects the current state of the art.
• UDI & GMDM Compliance: Maintain compliance with unique device identification (UDI) and Global Medical Device Nomenclature (GMDN) systems to track and identify devices accurately.
• Trending of Non-Serious Incidents: Detect patterns in non-serious incidents to prevent more significant issues from arising and improve patient outcomes.
• Correspondence Support: Manage communications with notified bodies, regulatory agencies, and competent authorities smoothly, especially for FSNs, FSCAs, and recalls.
• Change Management: Navigate substantial or significant product changes confidently to ensure ongoing compliance without market disruption.
• Complaint Handling and Investigations: Resolve customer complaints quickly and meet regulatory reporting requirements through thorough investigation processes.
• Adverse Event Reporting: Ensure timely and compliant reporting of adverse events to regulators, reducing risk and protecting patient safety.

Our PMS services extend beyond just meeting reporting obligations. We offer continuous monitoring of real-world data, including adverse event reports, field safety corrective actions (FSCAs), and recalls. These activities help identify trends that could affect the safety and performance of devices. For manufacturers selling devices globally, our team ensures that your surveillance programs meet the varied requirements of regulatory authorities in different regions, such as Periodic Safety Update Reports (PSURs) required under the EU MDR.

Additionally, we support manufacturers in responding to adverse event follow-up requests and deficiency letters from regulatory agencies. By maintaining an active PMS program, manufacturers can ensure their devices remain safe, effective, and compliant over time. With our expertise, we help companies streamline their post-market surveillance processes, providing real-time insight and data analysis to ensure regulatory compliance and patient safety. Whether preparing for audits or responding to adverse events, we are here to help you maintain compliance in an ever-evolving regulatory environment.

We have compiled a list of articles and training courses on the issue of post-market surveillance to help you and your colleagues.

Post-Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)
Our instructors review the requirements of post-market surveillance (Articles 83-86) and post-market vigilance (Articles 87-89) and provide expert advice for manufacturers throughout the course.

Post Market Surveillance: What You Need to Know to Ensure Patient Safety
In short, almost 60% of FDA citations between FY22 and FY24 were related to PMS issues, making this an issue that companies cannot afford to take lightly. It is critical for patient safety, to comply with regulatory requirements, and it makes manufacturers accountable.