Your business matters – that´s why we help healthcare companies meet global requirements with smart, scalable, and affordable software as well as real-world expertise. Our modern approach enhances compliance: it makes it intuitive, efficient, and aligned with your needs. We believe compliance should be manageable, so innovation doesn´t lose momentum.
EUDAMED-UDI compliance made affordable.
Global serialization compliance.
Situated in Germany, we are committed to ensuring comprehensive clarity in compliance with EU regulations. Our focus on IT security involves implementing robust measures to safeguard sensitive information. Furthermore, this enables us to deliver consistent, high-quality services that meet the evolving needs of both healthcare providers and patients.
Enjoy peace of mind in regulated environments. We provide ready-to-use software with intuitive interfaces and clear feedback so users feel confident with every action.
Our customer success team is always just one call away. With industry-leading support and a customer-first mindset, we’re here to help you succeed.
Our software ensures compliance with EU-FMD, MDR, DSCSA, and other global regulations – so you can operate seamlessly across borders. We reduce complexity in highly regulated landscapes for you.
Our mytracekey software includes comprehensive validation documentation, audit trails, and more. You’re always prepared for audits and inspections, without additional effort.
Keeping track of worldwide regulations and regulatory topics can feel like a never-ending marathon – we’re running with you! In this space, we are sharing our learnings, regulatory updates, and insights with you. Signing up for our newsletter helps you stay informed and on track.
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At the beginning of August 2025, EUDAMED contained around 800,000 registered medical devices. By the time this article was published in February 2026, this number has grown to over 1.2 million devices. This corresponds to an increase of roughly 400,000 products within half a year. For comparison: the European Commission conservatively […]
Read More… from EUDAMED Long-Term Solution – mytracekey UDI Manager
At first glance, the swissdamed upload appears simple: export a file from EUDAMED and import it into the Swiss database. But is it really that straightforward? Since many of our customers must work with both EUDAMED and swissdamed, we developed an additional module for swissdamed UDI compliance. In this article, we share our key […]
Read More… from Swissdamed Upload: Learnings from Our Developers and Customers
FAQ on EUDAMED and UDI. In our webinars on EUDAMED and UDI, we receive many questions about legacy devices, the M2M interface, XML bulk upload, timelines, and responsibilities. We have collected these questions and answered the most common ones for you in this EUDAMED and UDI compliance Q&A. Over the past months, we hosted four […]
Read More… from EUDAMED & UDI FAQ – The Most Important Questions on MDR, IVDR and Legacy Devices
