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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.

  • guideThe Benefits of EUDAMED for Manufacturers: Beyond Compliance

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    Two people sit at a table in a modern office, looking at a laptop screen together. Papers and a tablet are on the table, and large windows let in natural light from outside.

  • guideDifferences Between EUDAMED and GUDID: What Manufacturers Need to Know

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    Two professionals stand over a conference table with open binders, documents, and a laptop displaying financial charts, discussing data in a modern office with large windows overlooking city buildings.

  • guideThe Complete EUDAMED 2025–2026 Compliance Timeline

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    A desk with stacked binders labeled “Audit File,” “Device Records,” and “Regulatory Submissions,” next to organized file folders, documents, a tablet, pens, and a pencil by a bright window.

Articles & Webinar Replays

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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