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Resources for Medical Device Manufacturers

Regulatory Intelligence

Stay ahead of regulatory changes with expert resources on EUDAMED, GUDID, UDI, and medical device data governance.

This page gathers all ACKOMAS publications: in-depth articles on regulatory topics, webinar replays with downloadable materials, and practical compliance guides. Whether you are preparing for EUDAMED mandatory registration, structuring your UDI data governance, or evaluating how FDA and EU inspection frameworks affect your organization — each resource is designed to support informed decision-making for regulatory affairs and quality teams.

All content is freely accessible. Filter by type to find what you need.

  • MDR en 2025 : État des lieux et perspectives

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    Abstract image of a dark blue background with interconnected glowing blue dots and thin lines, evoking a digital network or neural connections—an ideal visual for illustrating EUDAMED implementation or UDI Standards best practices.

  • Étiquetage des dispositifs médicaux – Ce qui change avec EUDAMED

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    Abstract geometric background with overlapping blue and dark blue diagonal shapes and rectangles, creating a modern, layered design with sharp angles and gradients.

  • Data Version Management in EUDAMED

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    A woman sits at a desk with a computer displaying a spreadsheet, holding a printed balance summary sheet, and pointing at it with her finger. She appears to be reviewing financial information.

Articles & Webinar Replays

EXPLORE OUR LIBRARY

Browse our full collection of regulatory articles and past webinar recordings. Each resource covers a specific aspect of EUDAMED, GUDID, or medical device data governance — from compliance timelines to inspection frameworks.

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