The EU AI Act is reshaping medical device development by imposing strict transparency, risk, and data governance requirements, with global ripple effects. Smaller companies face disproportionate burdens, often relying on external platforms and partners, which adds risk. For QARA teams, globalization must be prioritized, as regulations vary widely across markets. Recent U.S. Supreme Court rulings, including Loper Bright and Corner Post, further complicate regulatory certainty, while cybersecurity emerges as a critical challenge with rising threats and complex insurance standards. To succeed, QARA must be integrated early, aligning with leadership to manage risk, compliance, and global market access.

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