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Post-Market Surveillance (PMS and PMCF)

Bioexcel Medical Device Research Organisation offer

Post-Market Surveillance (PMS and PMCF)

Bioexcel Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) services are vital for ensuring the ongoing safety and performance of medical devices in the post-market phase.

Bioexcel helps clients maintain the safety and performance of their medical devices in the post-market phase, ensuring ongoing regulatory compliance and patient safety. These activities are essential for identifying and addressing potential issues as they arise, contributing to the long-term success of medical devices.

PMS Plan Development:

  • Development of PMS Plans: Bioexcel assists in creating and implementing Post-Market Surveillance (PMS) plans for medical devices. These plans outline the systematic approach for monitoring the device’s safety and performance after it has been placed on the market.
  • Regulatory Compliance: The PMS plans developed by Bioexcel ensure compliance with regulatory requirements and standards, such as those mandated by the European Union’s Medical Device Regulation (MDR).
  • Long-Term Monitoring: PMS plans are designed to provide a framework for the long-term monitoring of devices. They include clear objectives, methodologies, and data collection procedures.
  • Risk Assessment: Bioexcel conducts risk assessments as part of PMS plan development to identify potential safety and performance issues. These assessments help in prioritizing surveillance activities and implementing risk mitigation strategies.

Data Collection and Analysis:

  • Continuous Data Collection: Bioexcel oversees continuous data collection in the post-market phase, utilizing various sources, including healthcare institutions, patients, and healthcare professionals. Data may include adverse events, device malfunctions, and patient outcomes.
  • Data Analysis: Bioexcel team of experts analyses the collected data to identify potential safety concerns, trends, or performance issues. The data analysis process is designed to provide early detection of any issues that may arise.
  • Timely Reporting: Bioexcel ensures that findings from data analysis are reported promptly. This reporting is a critical aspect of regulatory compliance and ensures that any necessary actions are taken to address identified concerns.
Help & FAQ

Frequently Asked Questions

PMS and PMCF are essential processes for monitoring the safety and performance of your medical device once it's on the market. They help identify potential safety concerns and ensure ongoing patient safety, regulatory compliance, and product effectiveness.

Bioexcel's experts create PMS plans tailored to your device. These plans outline the systematic approach for data collection, analysis, and risk assessment to continuously monitor your device's safety and performance.

We collect a range of data, including adverse event reports, complaints, user feedback, and clinical data. We analyze this data to identify trends, patterns, and safety issues, ensuring your device's ongoing safety and regulatory compliance.

Bioexcel maintains open communication with regulatory authorities and cooperates with them to ensure timely and accurate reporting. We follow regulatory requirements for reporting and are responsive to any requests or inquiries from authorities.

PMS and PMCF are critical in maintaining your device's market success. By addressing safety concerns promptly and ensuring ongoing product effectiveness, Bioexcel's PMS and PMCF services enhance patient safety, maintain regulatory compliance, and support the longevity of your device in the market.