Find here all our blog posts tagged with: design controls.
Design Controls Weren't Built for Models That Change
FDA is piloting exceptions rather than rewriting design controls for GenAI devices, leaving compliance leaders to build the continuous verification the rule doesn't require.
Design Controls Were Built for Outputs, Not Agentic Reasoning
FDA's total product life cycle framework for AI-enabled devices documents data lineage and output correctness, but not the intermediate process failures unique to agentic architectures.
