During a June 2025 webinar on pragmatic AI applications in healthcare quality management and regulatory affairs, live polling of quality and regulatory professionals revealed that approximately 80% of respondents were actively implementing AI solutions or seriously considering their use in quality management and regulatory activities.

This finding underscores a fundamental shift in how the healthcare industry approaches quality assurance and global regulatory compliance.

The enthusiasm for AI-enabled quality and regulatory processes isn’t unfounded. As quality and regulatory professionals navigate increasingly complex global requirements that span different product types, varying country-specific regulations, and evolving clinical applications, a pragmatic approach to AI presents an opportunity to improve one or more of process quality, process effectiveness, resource use, and global compliance while maintaining rigorous standards for patient safety and product quality.

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