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Post-Market Surveillance (PMS) for Medical Devices and In Vitro Diagnostic (IVD) Devices
Post-Market Surveillance (PMS) for Medical Devices and In Vitro Diagnostic (IVD) Devices Overview
- Post-Market Surveillance (PMS) Plan
- Post-Market Surveillance Report (PMSR)
- Periodic Safety Update Report (PSUR)
- Post-Market Clinical/Performance Follow-Up
- Annual Maintenance
Post-Market Surveillance (PMS) Plan
Pharma Wizard 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.
Post-Market Surveillance Report (PMSR)
Periodic Safety Update Report (PSUR)
Post-Market Clinical/Performance Follow-Up
Post-market Clinical Follow-up (PMCF) and Post-market Performance Follow-up (PMPF) are pivotal services offered by Pharma wizard 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
Pharma wizard Post-Market Surveillance End-To-End Services
Post-Market Surveillance (PMS)
End-to-end regulatory support for PMS report preparation.
Periodic Safety Update Report (PSUR)
Comprehensive PSUR compliance support.
Pharma Wizardās Post-Market Surveillance (PMS) Tailored Services
- SOP Writing
- Full-Time Employee (FTE) Support:
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.
