Post-market Surveillance (PMS) for Medical Devices and In Vitro Diagnostic (IVD) Devices Overview
Freyr offers comprehensive Post-market Surveillance (PMS) services for medical devices and In vitro Diagnostic (IVD) devices, ensuring compliance and safety throughout the lifecycle. Our tailored services include developing PMS plans, compiling reports, conducting clinical follow-ups, and providing annual maintenance support.
Freyr’s Post-Market Surveillance End-To-End Services
Post-Market Surveillance (PMS) Plan
Freyr offers tailored Post-market Surveillance (PMS) plan development services for both medical devices and In vitro Diagnostic (IVD) devices. Our experts collaborate closely with clients to formulate comprehensive PMS plans aligned with regulatory requirements and SOPs, ensuring continuous monitoring of device safety and performance throughout their lifecycle.
Post-Market Surveillance Report (PMSR)
For Class I medical devices and Class A IVD devices, Freyr provides specialized support in compiling Post-market Surveillance Reports (PMSRs). Our team conducts a thorough analysis of post-market data to assess device safety and performance, documenting findings in compliance with Regulatory standards.
Periodic Safety Update Report (PSUR)
Freyr offers PSUR services for Class IIa, Iib, and III medical devices and Classes B, C, and D IVD devices. Our experts compile comprehensive PSURs, incorporating data from Post-market Surveillance (PMS) activities, adverse event reports, and other sources to provide a comprehensive assessment of device safety and performance. At Freyr, the assessment of the PMS data will cover both reactive and proactive data collection system ensuring gaps in data generation and analysis.
Post-Market Clinical/Performance Follow-Up
Post-market Clinical Follow-up (PMCF) and Post-market Performance Follow-up (PMPF) are pivotal services offered by Freyr to navigate the complete lifecycle management of medical devices in accordance with the stringent requirements of the EU MDR and the EU IVDR.
Our team, comprising seasoned Regulatory experts, is adept at tailoring PMCF strategies to meet your specific needs while ensuring strict compliance with the EU MDR mandates. PMCF and PMPF stand as proactive and continuous processes, meticulously collecting and analysing clinical data to assess the real-world performance and safety of devices.
The objectives of PMCF encompass various critical aspects, including the ongoing evaluation of device performance and safety throughout its expected lifespan, the detection and monitoring of both known and unknown side-effects the identification and analysis of emergent risks, and the verification of intended device usage. By adhering to these rigorous standards, we ensure the continual safety and effectiveness of devices in everyday practice, benefiting patients, caregivers, and healthcare professionals alike.
Annual Maintenance
Freyr extends annual maintenance support for post-market Regulatory reports, including Post-market Clinical Follow-up (PMCF), Post-market Performance Follow-up (PMPF), and Periodic Safety Update Report (PSUR). Our specialized team ensures that these reports remain current, accurate, and compliant with Regulatory requirements over time. Through meticulous review and updates, we incorporate any changes in regulations, standards, or device performance data, ensuring ongoing adherence to Regulatory expectations and market demands.
Freyr’s Post-Market Surveillance End-To-End Services
Freyr’s Post-market Surveillance (PMS) Tailored Services
Freyr offers expert SOP writing services specifically tailored for Post-market Surveillance (PMS) activities. Our seasoned Regulatory experts collaborate closely with the manufacturers to develop standardized procedures and protocols that align with Regulatory requirements and industry best practices.
By crafting SOPs tailored to the unique needs of each manufacturer and their PMS processes, we ensure consistency, efficiency, and compliance throughout the surveillance lifecycle. These SOPs serve as invaluable tools for guiding personnel in conducting PMS activities effectively, enhancing data quality, and facilitating seamless Regulatory submissions.
Freyr provides dedicated Full-Time Employee (FTE) support to assist manufacturers in maintaining a proficient and specialized team for their Regulatory and compliance needs, including PMS services. Our flexible staffing solutions enable our partners to access skilled professionals on a full-time basis, ensuring consistent and dedicated resources to manage PMS activities efficiently.
