#IVDR

honestly rushing/ transition filings risks CAPA traceability and training regressions, submission quality beats speed. Use connected workflows so CAPA-driven risk assessment, traceability and training update together; automated CAPAs can help. がんばって #RegulatoryAffairs #MDR #IVDR

Good to be up and running plasma samples in 3mm mode within specs again! #nmr #nmrchat #ivdr

Diagnostics & biomarker testing are key to personalised and patient-centred #oncologycare As discussions on #IVDR continue, ESMO is contributing recommendations to support more efficient #ClinicalResearch in Europe 🔗 ow.ly/NRpQ50Z5a7T #CancerResearch #HorizonEU #ResearchImpactEU

vs CAPA divergence needs explicit process branches; qmsWrapper 10.2 Process Editor V2, visual grouping, checkpoint nodes, connection-trigger conditions and Risk Analysis automation, lets you model traceable, CAPA-driven connected workflows for each regime. #MDR #IVDR #MedTech

📖 The Full Spectrum of #Immunoassays From assay design to troubleshooting and regulatory frameworks—now in one comprehensive reference: 👉 doi.org/10.1007/978-... #Diagnostics #Antibodies #ProteinAnalysis #AssayDevelopment #IVDR

📢 #HealthierEurope. Better access. ESMO welcomes the @ec.europa.eu ’s Life Sciences Strategy - a bold step to reform #IVDR & support clinical innovation. Let’s ensure Europe leads in life sciences & #PatientsCare. 🔗 buff.ly/34j9638

icl 510(k) pitfall: traceability gaps in the DHF get exposed at notified-body audits. Auditors want true root-cause CAPA fixes, not closed tickets. Real fixes beat ticket counts. #MedDevice #MedTech #QMS #Compliance #RegulatoryAffairs #MDR #IVDR #ISO13485 #ISO14971 #FDA #qmsWrapper #AIinQMS

What are your predictions for #IVDR in 2025? After different delays and not without concerns, the implementation of IVDR, the new regulatory framework for in-vitro diagnostic in the EU has started. You can find the latest 2024 updates here as we look to year ahead! - bit.ly/4jmzVIi

💡 Un estudio liderado por VHIO, presentado en el congreso @myesmo.bsky.social, copresidido por Elena Garralda, analiza el impacto de la normativa #IVDR en los ensayos clínicos para agilizar el acceso a terapias innovadoras. ➡️ linke.to/ESMOTATVHIO26_Cast #UITM @caixaresearch.bsky.social

💡Last week at #ESMOTAT, co-chaired by Elena Garralda, the VHIO study on the impact of #IVDR on clinical trials was highlighted by the congress @myesmo.bsky.social, addressing key challenges in patient access to innovative therapies. ➡️ linke.to/ESMOTAT26VHIO #UITM @caixaresearch.bsky.social

🚀 Innovation is powerful, but responsible innovation is what makes a real difference. #AutoPiX #MedicalDevices #AIinHealthcare #DigitalHealth #MDR #IVDR #Rheumatology #Innovation #IHI

✨ We’re proud to have #AGES on board, helping us navigate the regulatory landscape and paving the way for trustworthy, future-proof AI-driven imaging technologies. #AutoPiX #RegulatoryScience #AIinHealthcare #MDR #IVDR #MedicalDevices #DigitalHealth #Innovation #IHI