
A practical, audit-defensible governance framework for marketing and promotional claims in regulated industries (IVD/MD/SaMD). The framework separates permissibility from exposure, applies tiered decision gates (GO/STOP/DEFER), and defines measurable KPIs for operational control. It includes a workflow, evidence thresholds, and scenario-based validation examples.DOI: https://doi.org/10.5281/zenodo.18473475License: CC BY 4.0.
claim governance marketing claims regulatory affairs quality management QMS IVDR MDR SaMD promotional compliance evidence-based claims risk management audit-defensible
claim governance marketing claims regulatory affairs quality management QMS IVDR MDR SaMD promotional compliance evidence-based claims risk management audit-defensible
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