『Reg with MEG』のカバーアート

Reg with MEG

Reg with MEG

著者： MedEnvoy Global
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Reg with MEG brings together industry experts to explore the ever-changing world of global medical device compliance. From EU MDR/IVDR and FDA pathways to regulatory importer obligations, Post Market Surveillance (PMS), and market access, we break down complex regulatory topics into clear, actionable conversations.MedEnvoy Global 経済学
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  • EU REP Symbol Replaces EC REP Symbol for Medical Device Labeling

    EU REP Symbol Replaces EC REP Symbol for Medical Device Labeling
    2026/06/24

    The European Commission has officially confirmed the transition from the EC Rep symbol to EU Rep symbol on medical device labeling. In this episode, we break down the new MDCG guidance, key compliance deadlines, labeling requirements, and what the change means for MDR and IVDR manufacturers. Learn how to update your labeling strategy, manage existing inventory, and prepare for the transition without disrupting market access.

    Note: This episode was created and hosted by AI

    #eurep #ecrep #medicaldevicelabeling #mdr #ivdr
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    10 分
  • Regulatory News Recap | FDA, TGA & Swissmedic Regulatory Updates

    Regulatory News Recap | FDA, TGA & Swissmedic Regulatory Updates
    2026/05/29

    In this episode, we break down three major global updates impacting medical device and digital health manufacturers: the FDA’s reclassification of skin cancer diagnostic devices, Australia’s new guidance on digital mental health software, and Swissmedic’s 2026 post-market surveillance campaign for higher-risk devices.Note: This episode was created and hosted with AI.
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    13 分
  • RAPS Euro Convergence 2026 Takeaways with Dean Adair

    RAPS Euro Convergence 2026 Takeaways with Dean Adair
    2026/05/28

    In this episode, MedEnvoy's Regulatory Affairs Consultant Dean Adair shares key takeaways from this year's RAPS Euro Convergence in Lisbon, Portugal, including the MDR/IVDR 2.0, the growing role of AI in medical device regulation, and the biggest compliance concerns manufacturers are facing across Europe.

    #rapseuroconvergence #mdr2.0 #ivdr2.0 #aimedicaldevice
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    21 分
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