Post Market Surveillance (PMS) for Medical Devices and In Vitro Diagnostic (IVD) Devices

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Post‑Market Surveillance (PMS) for Medical Devices and In Vitro Diagnostic (IVD) Devices

Ensure long‑term safety. Maintain global compliance. Strengthen product performance.

Masuu Global Solutions provides comprehensive Post‑Market Surveillance (PMS) support for medical devices and IVDs, enabling manufacturers to meet regulatory expectations throughout the entire product lifecycle. Our tailored PMS solutions cover everything from PMS planning to PSUR, PMSR, and PMCF/PMPF documentation—ensuring continuous monitoring of real‑world performance and regulatory‑ready reporting.

PMS for Medical Devices & IVDs – Overview

Our end‑to‑end PMS services help manufacturers achieve ongoing compliance under key global regulations including:
  • EU MDR (2017/745)
  • EU IVDR (2017/746)
  • FDA post‑market reporting requirements
  • Global vigilance frameworks

We support PMS plan development, data analysis, clinical/performance follow‑ups, and annual maintenance to ensure devices continue to meet safety, performance, and benefit‑risk expectations.

Masuu’s End‑to‑End PMS Services

  1. Post‑Market Surveillance (PMS) Plan Development
    2. We create customized PMS Plans for both medical devices and IVDs, aligned with:
    • EU MDR/IVDR requirements
    • Your internal SOPs
    • Device risk classification & intended use
    Each PMS Plan defines data sources, responsibilities, reporting timelines, and proactive surveillance strategies to monitor device performance throughout its lifecycle.
  1. Post‑Market Surveillance Report (PMSR)
    2. (For Class I medical devices & Class A IVDs) Our PMSR services include:
    • Comprehensive data collection & analysis
    • Assessment of real‑world safety and performance
    • Identification of emerging risks
    • Documentation prepared in full regulatory compliance
    We ensure clear, timely PMSRs that withstand regulatory scrutiny.
  1. Periodic Safety Update Report (PSUR)
    2. (For Class IIa, IIb, III devices & Classes B, C, D IVDs) Masuu compiles PSURs integrating:
    • PMS findings
    • Adverse event and vigilance data
    • Market feedback
    • Literature updates
    • Risk‑benefit evaluation
    • Proactive and reactive data collection
    Our PSURs ensure your documentation remains complete, accurate, and aligned with evolving EU MDR/IVDR expectations.
  1. Post‑Market Clinical Follow‑Up (PMCF) / Performance Follow‑Up (PMPF)
    2. PMCF (MDR) and PMPF (IVDR) are essential for demonstrating ongoing clinical/performance evidence. Masuu supports:
    • PMCF/PMPF plan development
    • Survey and registry‑based follow‑ups
    • Real‑world performance data collection
    • Long‑term safety & effectiveness evaluation
    • Analysis of known & unknown risks
    • Continuous verification of intended use
    Our experts ensure your PMCF/PMPF strategies meet the rigor expected under MDR/IVDR and maintain regulatory compliance throughout product life.
  1. Annual Maintenance & Lifecycle Reporting
    2. We manage annual PMS‑related updates including:
    • PMCF/PMPF updates
    • PSUR updates
    • PMS Plan revisions
    • Device performance and risk‑benefit reassessments
    • Gap corrections based on regulatory changes
    This ensures your PMS documentation always remains audit‑ready and compliant.

Masuu’s PMS Services Menu

  • Post‑Market Surveillance (PMS)
  • Periodic Safety Update Report (PSUR)
  • PMCF / PMPF documentation
  • PMSR development and updates

Masuu’s Tailored PMS Support

SOP Writing for PMS Activities

Masuu develops customized Standard Operating Procedures aligned with regulatory expectations and your organizational processes. Our SOPs ensure:
  • Consistent PMS activities
  • Clear workflows
  • Higher data quality
  • Seamless regulatory submissions
  • Effective internal audit readiness
Each SOP is tailored to your device classification, product risk, and global market distribution.

Full‑Time Employee (FTE) Support

Need ongoing PMS manpower?
Masuu provides dedicated FTE resources, including:
    >PMS specialists
  • Regulatory writers
  • Data analysts
  • Vigilance experts
Our flexible staffing models ensure you have consistent, skilled professionals supporting your PMS operations year‑round.
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