transition audit clock's ticking and half my group is still arguing: one register or two? Merged. Splitting = two stale docs nobody reconciles. MasterControl and Greenlight both default separate. Same headache, two price tags. 📋 #ISO9001 #RiskManagement #QualityEventSystem #qmsWrapper #ISO13485
October 20, 2026 at 10:46 PM
transition audit clock's ticking and half my group is still arguing: one register or two? Merged. Splitting = two stale docs nobody reconciles. MasterControl and Greenlight both default separate. Same headache, two price tags. 📋 #ISO9001 #RiskManagement #QualityEventSystem #qmsWrapper #ISO13485
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
June 23, 2026 at 11:51 AM
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
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
August 8, 2026 at 3:45 PM
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