Vanja Plicanic Samuelsson

Have you identified the #GrowthOpportunities in #MedicalImaging Equipment and Informatics? ⚕️🤔 Discover the transformative power of #AI-powered predictive analytics for equipment maintenance and enterprise #CloudBased imaging informatics in our recent #Growth Content. 🔗Click here to uncover how these advancements are revolutionizing #healthcare! https://hubs.la/Q02BdCtt0

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Are you ready to expand your Medical Device presence into the European market? Achieving CE marking is a crucial step in ensuring your products meet the stringent safety, performance, and regulatory requirements set by the EU Medical Device Regulation (MDR).   At Freyr, we provide a comprehensive solution to help you navigate the entire CE marking process, ensuring a smooth path to compliance and market entry.   Our specialized services cover all your needs:   - Regulatory Strategy & Classification: We help you identify and classify your device, determining the need for Notified Body (NB) audits based on classification. - Quality Management System (QMS): We implement an ISO 13485:2016-compliant QMS, tailored to your needs. - Clinical & Performance Data: We plan and execute studies, analyze data, and document results to support regulatory submissions. - Technical File Compilation: We prepare your technical file as per EU MDR 2017/745 or EU IVDR 2017/746 requirements, ensuring full compliance. - Notified Body Coordination: We handle all NB submissions, audits, and post-certification support. For more information click here.   Ensure your medical devices are compliant and market ready. Partner with us for a streamlined CE certification process and access to expert guidance throughout.   Contact us today for more information and start your journey towards CE marking success. https://lnkd.in/gGgEcdwF   #CEMarking #MedicalDevices #MDR #RegulatoryCompliance #GlobalMarketExpansion

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In today's fast-paced #healthcare environment, precision and efficiency are more critical than ever. The global market for #medicalcomputers is increasing, driven by the need for advanced #patientcare solutions. This blog explores the detailed applications of medical computers in #operatingrooms, intensive care units (#ICU s), and #diagnosticunits, focusing on the innovative and reliable solutions provided by #CureVision.

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#Wearablemedicaldevices are transforming healthcare by enabling real-time monitoring, personalized treatment, and proactive health management. As advancements in #sensortechnology, #AI, and #dataanalytics continue, these devices are becoming essential tools in managing #chronicdiseases and enhancing overall wellness. The growing prevalence of chronic conditions and the demand for #smarthealthcare solutions are driving significant growth in this market. https://lnkd.in/dHv-Mefu

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