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
Pharmaceutical serialization requirements are currently being introduced in Ethiopia in phases. According to the EFDA strategic plan, the stated objective is to combat pharmaceutical counterfeiting and enable greater transparency and efficiency throughout the supply chain. According to the WHO, one in ten […]
Read More… from Pharmaceutical Serialization Requirements in Ethiopia
RECOPS (Registro de Comercialización de Productos Sanitarios) is the database operated by the Spanish Agency of Medicines and Medical Devices (AEMPS, Agencia Española de Medicamentos y Productos Sanitarios) for the registration of medical devices and in vitro diagnostic medical devices (IVDs) intended for marketing […]
Read More… from RECOPS: Spain’s Medical Device Commercialisation Register
The Packaging and Packaging Waste Regulation (PPWR) applies across all industries. Consequently, manufacturers of medical devices and pharmaceuticals must generally also comply with the requirements of the regulation. However, exemptions are provided for certain applications in the pharmaceutical and medical technology sectors. […]
Read More… from Exemptions to the PPWR for MedTech and Pharma
