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Post-Market Surveillance (PMS and PMCF)

Proactive Monitoring for Medical Device Excellence: Ensuring Compliance with PMS & PMCF

Bioexcel offer

Post-Market Surveillance (PMS and PMCF)

Post-Market Surveillance

At Bioexcel, we provide end-to-end Post-Market Surveillance (PMS) services to help you monitor the safety, performance, and compliance of your medical device in real-world use. Our PMS solutions are tailored to meet global regulatory requirements, ensuring your device remains reliable and compliant throughout its lifecycle.

What is Post-Market Surveillance (PMS)?

PMS is a proactive and systematic process of collecting, analyzing, and interpreting data on the safety and performance of medical devices after they are introduced to the market. It is a mandatory requirement under EU MDR (2017/745), FDA regulations, and other global standards to ensure ongoing compliance and risk management.

Why PMS is Essential for Your Medical Device

  • Regulatory Compliance: Meet mandatory PMS requirements under EU MDR, US FDA, and CDSCO regulations.
  • Enhanced Safety: Identify potential risks and implement corrective actions to protect patients.
  • Product Improvement: Gain insights from real-world data to enhance device design and performance.
  • Market Trust: Build credibility with users and stakeholders by demonstrating a commitment to safety and quality.
Post-Market Surveillance

Our Post-Market Surveillance Services

In Vitro Diagnostic

PMS Plan Development

Structured Framework for Effective Monitoring

We create comprehensive PMS plans tailored to your device and regulatory requirements, ensuring systematic data collection and analysis.

Key Features:

  • Risk-based PMS planning in compliance with EU MDR Annex III.
  • Alignment with ISO 13485:2016 and ISO 14971:2019.
  • Integration of clinical and non-clinical data sources.
MATEROVIGILANCE

Periodic Safety Update Reports (PSUR)

Regulatory-Compliant Reporting for High-Risk Devices

We prepare and submit detailed PSURs for Class IIa, IIb, and III devices to demonstrate ongoing safety and performance.

Key Features:

  • Compilation of safety and performance data.
  • Trend analysis of adverse events and incidents.
  • Submission to Notified Bodies and regulatory authorities.

Post-Market Clinical Follow-Up (PMCF)

Continuous Evidence Generation Beyond Market Entry

Our PMCF services ensure your device’s clinical safety and performance are consistently monitored, as required by EU MDR.

Key Features:

  • PMCF plan and protocol development.
  • Real-world evidence collection and analysis.
  • PMCF study execution and reporting.

Adverse Event Reporting and Vigilance

Timely Detection and Resolution of Risks

We monitor and report adverse events, incidents, and field safety corrective actions (FSCA) to regulatory bodies in compliance with global standards.

Key Features:

  • Real-time tracking and analysis of adverse events.
  • Root cause analysis and CAPA implementation.
  • Reporting to EU MDR, FDA, and CDSCO authorities.

Real-World Data (RWD) Collection and Analysis

Insights for Continuous Improvement

We gather and analyze data from real-world use to assess your device’s long-term safety, efficacy, and user satisfaction.

Key Features:

  • Data collection from registries, surveys, and feedback.
  • Trend and pattern analysis for risk management.
  • Actionable insights for product enhancement.

Field Safety Corrective Actions (FSCA)

Proactive Safety Measures for Patient Protection

We assist in implementing FSCAs, including recalls, modifications, and public safety notices, to address safety concerns effectively.

Key Features:

  • Identification and execution of FSCAs.
  • Coordination with regulatory authorities.
  • Stakeholder communication and reporting.

Why Choose Bioexcel for PMS?

Regulatory Expertise

Compliance with EU MDR, US FDA, ISO 13485, and CDSCO standards.

Proactive Monitoring

Early detection of risks to prevent adverse outcomes.

Tailored Solutions

Customized PMS strategies for all device classes.

End-to-End Support

From PMS plan creation to reporting and corrective actions.

Quality Assurance
Help & FAQ

Frequently Asked Questions

Yes, PMS is mandatory for all medical devices as per EU MDR, FDA, and CDSCO regulations. The level of monitoring depends on the risk classification of the device.

PMS refers to overall post-market monitoring, while PMCF focuses on collecting and analyzing clinical data to verify ongoing device safety and performance.

PSURs must be updated annually for Class IIb and III devices and every two years for Class IIa devices, as per EU MDR requirements.

Ensure the long-term safety, performance, and compliance of your medical devices with Bioexcel’s expert Post-Market Surveillance services. Contact us today to streamline your PMS processes and build trust in your products.