Simplify Medical Data Compliance
The Fast Track to Medical Device Compliance
ACKOMAS offers a cutting-edge platform that ensures your medical devices comply with international regulations, such as EUDAMED and GUDID. Simplify data management, cut costs, and protect your information—all with one easy-to-use solution.
Achieve Compliance with Ease
Get Started with ACKOMAS
Transitioning to a streamlined compliance process is simple with ACKOMAS. Follow these steps to ensure your data is compliant, secure, and synchronized effortlessly.
Gather Essential Data
Efficiently collect all necessary product information to streamline your compliance process and save time.
Upload with Ease
Easily upload your product data to our intuitive platform, reducing manual effort and simplifying data management.
Ensure Compliance
Automatically verify your data to meet all regulatory standards, ensuring peace of mind and saving you valuable time and resources.
Seamless Sync
Effortlessly synchronize your data with regulatory databases, keeping your compliance up-to-date with minimal effort.
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Stay Ahead of the Curve
Join industry leaders to explore compliance intricacies and innovative solutions offered by ACKOMAS.
Latest from ACKOMAS and Regulatory Insights
Stay Informed and Up-to-Date
Stay ahead with the latest updates from ACKOMAS. Discover valuable insights on our upcoming webinars, medical device regulation news, FAQs about compliance, and the latest company developments. Stay informed and ensure your business remains compliant and competitive.
Get Ready for EUDAMED – Join or Replay Our Expert Webinars
Stay ahead of regulatory deadlines with our free expert-led webinars. In just 30 minutes, get actionable guidance on EUDAMED, MDR, and IVDR. Learn how to streamline your compliance strategy and avoid costly mistakes.
The Benefits of EUDAMED for Manufacturers: Beyond Compliance
EUDAMED is more than a compliance checkbox. By standardising data, boosting product visibility and enabling proactive vigilance, the database can streamline processes, cut costs and sharpen competitive edge. This article shows manufacturers how turning regulatory obligations into operational wins can power digital transformation and strengthen market positioning across Europe.
Differences Between EUDAMED and GUDID: What Manufacturers Need to Know
EUDAMED and GUDID both aim to strengthen device traceability, yet they differ sharply in scope, structure and terminology. This article compares Europe’s six-module, Basic UDI-DI-centric database with the FDA’s UDI-focused GUDID, outlining the practical implications—and compliance pitfalls—for manufacturers selling into both regions.
The Complete EUDAMED 2025–2026 Compliance Timeline
EUDAMED is moving from voluntary to mandatory: Regulation (EU) 2024/1860 locks in 2025–2026 deadlines. This concise timeline explains what changes, who is affected and when—so manufacturers, authorised representatives and importers can prioritise registrations, deploy M2M connections, report supply disruptions on time and maintain EU market access.
Your Roadmap to Seamless EU Compliance
From first Basic-UDI upload to bulk declarations, our articles walk you through every milestone—without the jargon.
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Never miss an update in medical device regulations, industry news, and exclusive insights from ACKOMAS. Join our community for essential updates, expert advice, and learning opportunities.
ACKOMAS will never share your data with anyone outside the company—for marketing or any other purpose. 100% GDPR compliant.
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