June 2025

Who is EUMEDIQ, anyway? This time: Gabi

What is your area of expertise? I started in quality management at Medela AG in Baar 8 years ago. Document management, digital and physical archiving of process documents, labelling. I supported the creation and maintenance of technical documentation. I work in Quality Support at EUMEDIQ. Processing customer inquiries and organizing relevant documents are part of […]

New MDCG Guidance: AI Act and MDR/IVDR – What MedTech manufacturers need to know

Knowledge & Resources / EuMe-adm

This month, the MDCG, together with the Joint Artificial Intelligence Board, published a guidance document on how to handle AI-enabled medical devices under the forthcoming AI Act (AIA) in parallel with existing requirements under the MDR/IVDR. The document introduces the term Medical Device AI systems (MDAIs) and provides a structured overview of how the two

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Who is EUMEDIQ, anyway? This time: Gabi

New MDCG Guidance: AI Act and MDR/IVDR – What MedTech manufacturers need to know

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