“Initially, we budgeted for a full-time hire. Today, two of us manage 20,000 UDIs in just a couple of hours per week.”
Ackomas connects directly with EUDAMED, GUDID, Swissdamed, FDA, and other global regulatory databases.
Automate data management, ensure security, and keep your products continuously market-ready.
Submit and synchronize regulatory data worldwide — no spreadsheets, no errors.
Stay ahead of regulatory changes with real-time alerts and proactive updates — no delays, no risks.
Keep your product registrations up to date across EUDAMED, GUDID, and Swissdamed — always audit-ready, always compliant.
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.
Efficiently collect all necessary product information to streamline your compliance process and save time.
Easily upload your product data to our intuitive platform, reducing manual effort and simplifying data management.
Automatically verify your data to meet all regulatory standards, ensuring peace of mind and saving you valuable time and resources.
Effortlessly synchronize your data with regulatory databases, keeping your compliance up-to-date with minimal effort.
Stay Ahead of the Curve
Join industry leaders to explore compliance intricacies and innovative solutions offered by ACKOMAS.
Browse our full collection of regulatory resources. Each one covers a specific aspect of EUDAMED, GUDID, UDI, or medical device data governance.
EXPLORE OUR LIBRARY
Complete guide to register medical devices in EUDAMED: UDI-DI submission, Basic UDI-DI, deadlines, legacy devices,…
Santex S.p.A. shares how they achieved MDR and EUDAMED compliance with ACKOMAS. A 30-minute live…
The FDA's updated Compliance Program 7382.850 (February 2026) formally establishes GUDID as an inspectable, mandatory…
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.
Receive concise updates on MDR/IVDR regulatory changes, EUDAMED registration deadlines, and GUDID compliance requirements. Built for RA/QA and regulatory affairs teams. No promotional content — only actionable changes.
🔒 Our Commitment
ACKOMAS will never share your data with anyone outside the company—for marketing or any other purpose. 100% GDPR compliant.
Watch recorded sessions on EUDAMED registration, UDI structuring, and data governance
Be notified when EUDAMED deadlines, MDCG guidance, or submission rules change
Practical resources to prepare for audits, structure your UDI data, and manage multi-market registration