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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.

  • GUDID at the Heart of the FDA Framework: In-Depth Analysis of Its Link to Compliance Program 7382.850

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    Text graphic stating: "GUDID IS NOT OPTIONAL. FDA Framework - Compliance Program 7382.850." On the right, it reads: "INSPECT VERIFY ENFORCE." Black background with green and white text.

  • GUDID & EUDAMED: What Inspection Frameworks Reveal About Regulatory Data Governance

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    A gloved hand holds a white box with a UDI barcode label, displaying product information and manufacturing date, in front of a blurred computer screen showing a form—essential for regulatory data governance and GUDID compliance.

  • EUDAMED 2026 : passer en production en toute confiance

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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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