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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.

  • guideWhat is EUDAMED and why is it important for medical device manufacturers?

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    A checklist titled "Governance assessment" with three checked boxes sits on a wooden desk next to a closed notebook and a pen, with soft natural light coming through a window in the background.

  • guideEUDAMED Terminology: Regulatory Vocabulary Guide

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    Three people sit around a table with laptops and documents, discussing in a bright office. Behind them, a flip chart displays “Co-Marketing” and various charts and illustrations.

  • webinarEUDAMED 360° – UDI Standards, Strategies & Best Practices

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    Abstract dark blue background with a central glowing dot connected to several smaller dots by thin, curved lines, forming a network that evokes EUDAMED and UDI standards. Subtle geometric shapes overlay the backdrop, reflecting best practices in data connectivity.

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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