Quality and Regulatory Professionals Question a Future with Cybersecurity Issues, US

6 Pages

This brief summarizes insights from industry leaders discussing the growing impact of cybersecurity threats, evolving litigation risks, and AI regulation on quality and regulatory affairs (QARA). It highlights concerns around cyber vulnerabilities in digital health products, regulatory uncertainty following recent U.S. court rulings, and compliance with the EU AI Act. The paper emphasizes early QARA involvement, cross-functional governance, and proactive risk mitigation to protect patients, products, and organizations.

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Quality and Regulatory Professionals Question a Future with Cybersecurity Issues, US

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