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