AI Act transparency duties are live; our QMS AI assistant disclosure remains unclear, and 'probably fine' on Friday is not a compliance posture I'm comfortable with. #AIQMS #qmsWrapper #QualityEventSystem #ISO13485 #MedTech #RegulatoryAffairs

Real talk: SME supplier qualification still hinges on PDFs, not live audit trails. Do ISO13485 controls cover SaMD updates too, with linked DHF/CAPA trails to survive notified-body reviews? #qmsWrapper #QualityEventSystem #MedTech #ISO13485 #Traceability #AuditReady #ChangeControl #AIQMS