PMCF and PSUR: Strengthening Medical Device Safety
August 27, 2026Medical device compliance does not end when a product enters the market. Once devices are being used by healthcare professionals and patients, manufacturers need reliable systems to understand real-world performance, identify potential risks, and determine whether additional safety measures are necessary. This is where PMCF medical devices and PSUR medical devices become important parts of post-market regulatory management. Both activities support ongoing evaluation, but they serve different purposes. Understanding how they work together can help manufacturers build a stronger post-market surveillance strategy and maintain...