ACKOMAS

📢 Attention Medical Device Manufacturers: The Future of EUDAMED Compliance is Here! With the mandatory use of EUDAMED just around the corner, the focus is on ensuring a smooth transition for manufacturers and stakeholders. 🌟 Key Takeaways from Industry Insights: ✔️ Preparation is Essential: Reliable timelines, technical documentation, and transitional rules are critical for effective onboarding. ✔️ Improved Efficiency: EUDAMED consolidates data from multiple registries, enhancing accessibility and reducing redundancies. ✔️ Support for SMEs: Tailored onboarding solutions will ensure accessibility for small and medium-sized enterprises, fostering compliance across the board. At ACKOMAS, we’re leading the charge in simplifying the transition to EUDAMED. Our solutions ensure data integrity, compliance, and seamless integration with this critical infrastructure. 💬 Join the conversation: How is your organization preparing for EUDAMED? Let us know your thoughts or challenges below! 📩 Request a Demo today to see how ACKOMAS can support your compliance journey! #EUDAMED #MedicalDevices #RegulatoryCompliance #HealthcareInnovation

📢 Important Update for Medical Device Manufacturers in Europe! The European Commission has issued crucial clarifications on the information obligation for supply interruptions and discontinuations under Article 10a of MDR/IVDR, effective January 10, 2025. What’s New? Manufacturers must now notify: 1️⃣ Competent authorities, health institutions, and healthcare professionals about anticipated supply disruptions. 2️⃣ Ensure notification is provided at least six months in advance (except under exceptional circumstances). This amendment is a game-changer for ensuring patient safety and healthcare continuity across the EU. It also emphasizes the need for robust supply chain monitoring and proactive communication strategies. Why It Matters: 🛡️ Enhances transparency in the supply chain. ⏱️ Allows stakeholders to prepare mitigating measures in advance. ⚕️ Safeguards patient health by reducing risks from device unavailability. At ACKOMAS, we specialize in automating compliance workflows, including synchronized EUDAMED integration. Our solutions ensure manufacturers are ready to meet evolving regulatory demands seamlessly. 💬 Are you ready for the 2025 deadlines? Join the conversation below or contact us for solutions tailored to your compliance needs. 📩 Request a Demo or learn more on our website. Let’s make compliance simple and impactful! 💼 #MDR #IVDR #EUDAMED #MedicalDevices #RegulatoryCompliance

[ENG] We are thrilled to have been selected for the pitch session at the Meet & Match event in Strasbourg, taking place on November 28, 2024, organized by BioValley France and BIOPRO Baden-Württemberg GmbH. We are excited to participate in events organized jointly by the health cluster of Alsace and the Grand Est region (BioValley France) and the healthcare-focused state agency of Baden-Württemberg (BIOPRO), showcasing excellent cross-border cooperation on shared health sector challenges. Kristina Iancu will represent ACKOMAS on stage for the pitch session at 12:00 PM – don’t miss it! [GERM] Wir freuen uns, für die Pitch-Session der Meet & Match-Veranstaltung in Straßburg am 28. November 2024 ausgewählt worden zu sein, die von BioValley France und BIOPRO Baden-Württemberg GmbH organisiert wird. Unsere Präsentation findet um 12:00 Uhr statt – verpassen Sie sie nicht! Es ist uns eine Freude, an Veranstaltungen teilzunehmen, die gemeinsam vom Gesundheitscluster aus dem Elsass und der Grand Est Region (BioValley France) und der Landesagentur der Gesundheitsindustrie Baden-Württemberg (BIOPRO) organisiert werden. Wir freuen uns über die tolle grenzüberschreitende Zusammenarbeit bei gemeinsamen Herausforderungen im Gesundheitsbereich. [FR] Nous sommes ravis d'avoir été sélectionnés pour la session de pitch de la journée Meet & Match à Strasbourg, qui aura lieu le 28 novembre 2024, organisée par BioValley France et BIOPRO Baden-Württemberg GmbH. Nous sommes heureux de participer à des événements organisés conjointement par les clusters de santé du Grand Est (BioValley France) et l'agence publique de Bade-Wurtemberg axée sur la santé (BIOPRO) et de constater une belle coopération transfrontalière sur des défis communs dans le domaine de la santé. Kristina Iancu représentera ACKOMAS lors de la session de pitch à 12h – à ne pas manquer !

🔍 Master UDI-DI Implementation for Contact Lenses: Are You Ready? The latest MDCG guidance is here, detailing the requirements for Master UDI-DI assignment specifically for contact lenses. This crucial step ensures better traceability, compliance, and data integrity under EUDAMED regulations. At ACKOMAS, we simplify the journey with seamless integration and support for managing your compliance processes effectively. #EUDAMED #MasterUDIDI #ComplianceSimplified #MedicalDevices

🎉 A successful day at About Medical Devices 2024 in Milan! 🇮🇹 Today, Valerio GIGANTE represented ACKOMAS at this pivotal event, engaging with industry leaders and innovators to discuss the future of medical device compliance. 💡 Key takeaways: - Simplifying compliance with seamless EUDAMED integration. - Turning regulatory challenges into opportunities for growth. - Empowering manufacturers with innovative, reliable solutions. We were thrilled to connect with so many passionate professionals and share how the ACKOMAS platform is reshaping regulatory compliance. Let’s continue the conversation—reach out to us to learn more! 🚀 #MedicalDevices #EUDAMED #Compliance #Innovation #AboutMedicalDevices2024 #RegulatoryExcellence

🚨 ACKOMAS in diretta da About Medical Devices 2024 a Milano! 🇮🇹 Oggi, 26 novembre 2024, Valerio GIGANTE, il nostro Account Executive per l’Italia e la Spagna, partecipa a questo evento fondamentale dedicato al futuro dei dispositivi medici. Vi aspettiamo presso l’Hotel NH Milan per scoprire come la piattaforma ACKOMAS sta rivoluzionando la gestione dei dati normativi. 🎯 Perché incontrarci oggi? - Sincronizzazione fluida con EUDAMED: Semplificate i vostri processi e rispettate le normative senza stress. - Soluzioni innovative: Trasformate le sfide normative in opportunità di crescita. - Esperienza riconosciuta: Una soluzione progettata per garantire la conformità e proteggere le vostre operazioni. 📍 Venite a trovarci e discutiamo insieme dei vostri progetti! 🚀 #ACKOMAS #DispositiviMedici #EUDAMED #Conformità #Innovazione #AboutMedicalDevices2024 #EccellenzaRegolatoria

🌟 EUDAMED: A Progressive Transition to Prepare for Now 🌟 With the MDR/IVDR 2024 regulation, Europe is initiating a transition to EUDAMED, providing a structured framework to strengthen compliance and transparency for medical devices. Each step is critical to anticipate, ensuring your readiness and avoiding costly interruptions. ⏳ 👉 Key Takeaways: - An early rollout of modules: Use this time to structure your processes. - Critical deadlines not to miss, or risk non-compliance. - An opportunity to modernize your data management while meeting regulatory requirements. At ACKOMAS, we are ready to support you today with solutions that ensure you stay ahead of deadlines and move forward with confidence. 🌍 📩 Request a demo of our platform today and turn these obligations into a competitive advantage. Don’t let time catch up with you! #RegulatoryCompliance #EUDAMED #HealthInnovation #MedicalDevices #ActNow

📢 Auf dem Weg zu IVDR 2.0 🚀 Das ACKOMAS-Team wird am 27. November an der IVDR 2.0 Veranstaltung des Verbands der Diagnostik-Industrie (VDGH): Eine Gelegenheit, um mit Branchenführern in Kontakt zu treten und Einblicke zu gewinnen, wie die IVDR-Konformität mit innovativen Lösungen optimiert werden kann. ✔️ Was erwartet Sie? - Diskussionen zu rechtlichen und untergesetzlichen Regelungen, die die Zukunft der IVDR prägen. - Einblicke von führenden Vertretern des Europäischen Parlaments, des Gesundheitsministeriums, der EU-Kommission und weiteren wichtigen Akteuren. 📍 Ort: DECHEMA, Theodor-Heuss-Allee 25, 60486 Frankfurt am Main 🌐 Details: www.ivdr.de

The ACKOMAS team will be present on the 27 of November at IVDR 2.0, event organised by the Verband der Diagnostik-Industrie (VDGH), the German Association of the Diagnostics Industry: an in-depth event to engage with industry leaders and gain insights on how to streamline IVDR compliance using innovative solutions. ✔️ What’s in it for you? - Discussions on legal and sub-legal regulations shaping the future of IVDR. - Insights from key representatives of the European Parliament, Ministry of Health, the EU Commission, and other major stakeholders. Don’t miss the opportunity to connect with us and learn more about how we can support your regulatory journey. 📍 Venue: DECHEMA, Theodor-Heuss-Allee 25, 60486 Frankfurt am Main 🌐 Details: www.ivdr.de

🚀 Letzter Tag auf der Healthcare live! 2024 - Nutzen Sie die Gelegenheit! Heute sind wir noch im H4 Hotel Hannover Messe, um über die digitale Transformation und die regulatorische Compliance im Gesundheitswesen zu sprechen. Nutzen Sie diesen letzten Tag, um Kristina Iancu und Stéphane Anceléphane zu treffen und zu entdecken, wie die ACKOMAS-Plattform die Synchronisation Ihrer Daten mit regulatorischen Datenbanken wie EUDAMED und GUDID vereinfachen kann. Lassen Sie uns über Ihre Herausforderungen und die maßgeschneiderten Lösungen sprechen, die wir bieten! #HealthcareLive2024 #RegulatorischeKonformität #DigitalGesundheit #EUDAMED #Innovation