Regulation 2026-11-07· Regulatory Affairs Professionals Society
Regulatory Experts Urge Comprehensive Frameworks for Healthcare AI
Speakers at the RAPS AI in Regulatory Conference called for streamlined European frameworks and greater regulatory literacy regarding healthcare AI applications. Experts cautioned that teams must look beyond initial software validation to institute standardized post-market change controls. The guidance emphasizes aligning machine learning health tools with international quality standards like ISO 13485.
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