A structured document outlining the processes for monitoring the safety and performance of a medical device after it has been released onto the market. It details methods for collecting and analyzing data related to device usage, potential adverse events, and performance issues. An example would be a document specifying data collection through user surveys, analysis of complaint logs, and periodic review of published clinical literature concerning a specific implantable device.
Its significance lies in proactively identifying and mitigating risks associated with medical devices, ensuring patient safety and regulatory compliance. A well-executed plan facilitates timely corrective actions, preventing potential harm and maintaining public trust. Historically, the need for such a framework arose from instances where post-market issues, undetected early, resulted in significant health consequences, prompting regulatory bodies to mandate rigorous monitoring processes.
