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MDCG publishes Revision 5 of its Guidance on IVDR Classification Rules

The MDCG has updated its guidance on the classification of in vitro diagnostic medical devices (IVDs) under the IVDR, providing (...)

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Navigating ISO 10993-1:2025 in Practice: What’s Changed and What Regulators Expect Now

GMED Expert Shahriar Sharifi to Share Insights on ISO 10993-1:2025 and Evolving Biocompatibility Expectations Shahriar Sharifi, PhD, GMED expert in (...)

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AMDM IVD Diagnostics Sector Webinar Series

GMED Expert Tom Patten to Present on Lessons Learned from IVDR Notified Body Assessments Tom Patten, IVD International Manager at (...)

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