This paper explores how postmarket surveillance (PMS) ensures medical device safety, compliance, and performance. With stricter regulations like the EU MDR, companies must shift from reactive monitoring to proactive, technology-enabled PMS. Best practices include integrating real-world evidence, using AI-driven analytics, automating adverse event reporting, and harmonizing global processes. A robust PMS program not only reduces regulatory risk but also lowers costs, supports faster corrective actions, and strengthens market confidence. Properly executed, PMS becomes a strategic advantage, improving patient outcomes and brand reputation.

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