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:
Data Collection and Analysis:
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.
TO BREAK THE BARRIERS OF TRADITIONAL CLINICAL INVESTIGATION FOR MEDICAL DEVICE INDUSTRY
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