# Postmarket Surveillance (PMS)

This narrative review, based on structured searches of PubMed and ScienceDirect (2016-2026, plus a clinical-research-focused search for 2013-2026) supplemented by FDA, EMA, Cochrane Library, and industry sources, examines medical device safety across the full lifecycle from early design and clinical investigation through regulatory review, postmarket surveillance, software change management, cybersecurity, and AI/ML-enabled device oversight, arguing that device safety requires a broader socio-technical framework than drug safety and that safety evidence is shifting from retrospective, passive reporting toward proactive, real-time, lifecycle-based generation.

This narrative review, based on structured searches of PubMed and ScienceDirect (2016-2026, plus a clinical-research-focused search for 2013-2026) supplemented by FDA, EMA, Cochrane Library, and industry sources, examines medical device safety across the full lifecycle from early design and clinical investigation through regulatory review, postmarket surveillance, software change management, cybersecurity, and AI/ML-enabled device oversight, arguing that device safety requires a broader socio-technical framework than drug safety and that safety evidence is shifting from retrospective, passive reporting toward proactive, real-time, lifecycle-based generation.