Post Market Surveillance
Post Market Surveillance (PMS) is a systematic process used in regulated industries, particularly medical devices and pharmaceuticals, to monitor the safety and performance of products after they have been released to the market. It involves collecting, analyzing, and acting on data from real-world use to identify potential risks, adverse events, or opportunities for improvement. This methodology ensures ongoing compliance with regulatory requirements and helps maintain product quality and patient safety throughout the product lifecycle.
Developers should learn about Post Market Surveillance when working on software for medical devices, healthcare applications, or any regulated product where safety monitoring is critical, such as in FDA-regulated environments in the US or under EU MDR/IVDR in Europe. It is essential for implementing features like adverse event reporting systems, data analytics dashboards for safety signals, and automated compliance workflows, ensuring that software supports regulatory obligations and risk management post-launch.