Medical device recalls are rising, with 2022 seeing nearly 12,000 events affecting 62 million products worldwide. The FDA urges MedTech companies to be recall-ready, emphasizing voluntary recalls as the fastest way to protect patients. Challenges include patient safety risks, reputational damage, financial losses, and regulatory penalties. Effective recall-readiness requires a trained core team, clear procedures, communication plans, and regular mock recalls. IQVIA MedTech’s Global Recall Program offers scalable, tech-enabled support with a 3,500-member team and automated recall platform, helping companies respond quickly, maintain compliance, and safeguard trust.

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