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.
Read more: UDI Management | Pharma Serialization | Other topics | White Paper & Downloads | HR Blog
Since the entry into force of Regulation (EU) 2021/2226 at the beginning of 2022, manufacturers have been permitted, under certain conditions, to provide instructions for use for medical devices in electronic form (eIFU). With Regulation (EU) 2025/1234, the European Commission has further developed the original framework […]
Read More… from eIFU Requirements: What Manufacturers and Providers Need to Consider
With a population of around 1.6 million, Bahrain is one of the smaller markets in the Middle East. Nevertheless, the Kingdom plays a much larger role for international pharmaceutical companies than its population size might suggest. Thanks to its central location in the Gulf region, a population with strong purchasing power […]
At first glance, the idea of a globally harmonized UDI system seems logical. Uniform identifiers, standardized data, and clearly structured processes should simplify the international trade of medical devices while strengthening patient safety. In reality, however, a far more complex picture emerges. […]
