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Home - Medical Device Software Development Europe

    https://medicaldevicesummit-europe.com/
    Providing Regulatory, Quality, and Technical Medical Device Software Teams with Practical, Implementable Strategies for Designing and Validating Compliant, …

Software Design for Medical Devices Europe - Royal …

    https://www.rsc.org/events/detail/16723/software-design-for-medical-devices-europe
    Software Design for Medical Devices Europe 27 - 28 January 2015, Munich, Germany Introduction Finding and maintaining the balance between compliance and the …

Software as a Medical Device in Europe - Morrison

    https://lifesciences.mofo.com/topics/software-as-a-medical-device-in-europe--new-regulatory-regime-about-to-enter-into-force--part-1-of-6
    Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6) By: Wolfgang Schönig, Stephan Kreß and Robert …

Software Design for Medical Devices

    https://www.pharma-iq.com/events-sdmdglobal
    Medical Devices have the potential to revolutionise medical treatments, diagnostics, patient engagement and quality …

Software as a Medical Device - Demystifying EU MDR

    https://www.med-technews.com/medtech-insights/medtech-regulatory-insights/software-as-a-medical-device-demystifying-eu-mdr/
    As per the European Commission’s Medical Device Coordination Group (MDCG), Medical Device Software (MDSW) is a software intended to be used, alone or …

Software Design for Medical Devices (SDMD) Global - Clocate

    https://www.clocate.com/software-design-for-medical-devices-sdmd-global/10299/
    The Software Design for Medical Devices (SDMD) Global is a conference focused on medical device software standards, regulatory compliance and development including: …

European guidance on MDR, IVDR …

    https://www.emergobyul.com/news/new-guidance-published-medical-device-and-ivd-cybersecurity-under-mdr-and-ivdr-europe
    The guidance also clarifies that at EU level, the NIS Directive (EU) 2016/1148 and the General Data Protection Regulation (EU) 2016/679 (GDPR) are relevant …

Medical Device Software Development

    https://www.scnsoft.com/healthcare/medical-devices
    Software as a Medical Device (SaMD) Target devices: Smartphones, tablets. PCs, laptops. Smartwatches and wearable fitness trackers. Smart TV. Use cases: AI-based …

MedTech Europe, from diagnosis to cure

    https://www.medtecheurope.org/
    We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made …

Guidance - MDCG endorsed documents and other guidance

    https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
    This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro …



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