This white paper explores how post‑market surveillance is evolving from a reactive, complaint‑driven function into a proactive, data‑driven discipline focused on patient safety and product performance. It outlines global regulatory expectations under EU MDR, IVDR, and FDA frameworks, emphasizing the need for multi‑source data, integrated quality processes, and closed‑loop feedback into risk management and clinical evaluation. The paper also demonstrates how digitized, AI‑enabled QMS and RIM platforms can transform PMS into a strategic advantage for both compliance and commercial agility.
Outdated compliance practices aren't viable amid evolving market and regulatory changes. IQVIA’s award-winning, end-to-end quality management system streamlines the product value chain, accelerates market entry, safeguards companies and patient safety, and meets complex regulatory demands.
SmartSolve® RIM manages regulatory submissions, product registrations, and health authority interactions.
Discover how an end-to-end eQMS solution empowers QARA professionals to remain agile, well-informed, and proactive in ensuring the safety and efficacy of medical devices.
Replace spreadsheets and disconnected tools with a single eQMS for deviations, audits, CAPAs, and approvals. SmartSolve® helps pharma teams maintain control, reduce compliance risk, and support regulatory readiness.
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