『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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  • 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
  • Navigating Mexico's Medical Device Market

    Navigating Mexico's Medical Device Market
    2026/05/11

    Find out about the complexities of Mexico’s medical device regulations, from COFEPRIS registration and distribution to warehousing compliance and technovigilance reporting. Learn what manufacturers need to know to successfully navigate the Mexican market.

    Note: This episode was created and hosted with AI.

    #cofepris #mexicodeviceregistration #medicaldeviceregistration #medicaldevicecompliance
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    11 分
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