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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For many years, the Medical Device Directive (MDD), published on July 12, 1993, formed the regulatory basis for medical devices in the European Union. With technological progress, growing market complexity, and several serious safety incidents, it became clear that the MDD no longer met current requirements. Consequently, the EU initiated a reform process. This process […]
Whether a small business or a global medical device manufacturer: MDR and IVDR requirements raise similar questions for most companies. How can UDI data from different systems be reliably consolidated? What steps are necessary to prepare my data for EUDAMED? And which solutions support the submission of large UDI volumes to […]
Anyone who places a medical device on the Australian market must upload it to the Therapeutic Goods Administration (TGA) database. However, not every manufacturer has the same responsibilities. Within the AusUDID, these responsibilities depend on the company’s location. The system distinguishes between manufacturers and sponsors […]
