“Initially, we budgeted for a full-time hire. Today, two of us manage 20,000 UDIs in just a couple of hours per week.”
Global Compliance, Made Simple.
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.
Automate Compliance
Submit and synchronize regulatory data worldwide — no spreadsheets, no errors.
Secure & Audit-Proof
Stay ahead of regulatory changes with real-time alerts and proactive updates — no delays, no risks.
Always Market-Ready
Stay ahead of regulatory changes with real-time alerts and proactive updates — no delays, no risks.
“We chose the only solution that addressed both our technical needs and regulatory obligations—Ackomas.”
“Ackomas’ solution makes regulatory compliance and data security remarkably easy and accessible—even without an IT team.”
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.
See ACKOMAS in Action
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.
What is EUDAMED and why is it important for medical device manufacturers?
Digital transformation impacts every sector, including medical devices. At the heart of this regulatory revolution lies EUDAMED (European Database on Medical Devices), an ambitious initiative by the European Commission that redefines transparency and traceability standards for medical devices in Europe.
For manufacturers, understanding EUDAMED is not just a matter of compliance but also a strategic opportunity in an increasingly demanding European market.
EUDAMED Terminology: Regulatory Vocabulary Guide
Understanding the vocabulary specific to EUDAMED is essential for navigating the regulatory landscape of medical devices in Europe effectively. This practical guide aims to clarify the technical terms and acronyms frequently used in the context of EUDAMED, thereby enabling industry professionals to communicate more efficiently and better grasp the associated regulatory requirements.
EUDAMED Terminology: Regulatory Vocabulary Guide
Understanding the vocabulary specific to EUDAMED is essential for navigating the regulatory landscape of medical devices in Europe effectively. This practical guide aims to clarify the technical terms and acronyms frequently used in the context of EUDAMED, thereby enabling industry professionals to communicate more efficiently and better grasp the associated regulatory requirements.
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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ACKOMAS will never share your data with anyone outside the company—for marketing or any other purpose. 100% GDPR compliant.
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