This IQVIA white paper highlights how medical device regulations are expanding rapidly, with 15+ new regulations, 60+ guidelines, and 100+ amendments in just five years. Static QARA systems can’t keep pace, leading to compliance risks, delays, and higher costs. The paper advocates for dynamic data systems powered by AI, enabling real-time monitoring, predictive compliance, and flexible workflows. The QARA AI agent supports live data harvesting, intelligent extraction, predictive models, and adaptable workflows to harmonize global launches. Though challenges include regulatory complexity, data security, and AI transparency, firms adopting dynamic strategies gain agility, faster approvals, reduced recalls, and global market access.

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