tracekey solutions GmbH
RegTech for Life Science Industry
The better way to stay compliant.
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.
MedTech
EUDAMED-UDI compliance made affordable.
Pharma
Global serialization compliance.
Customer References
Made in Europe – We build trust
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.
- Over 10 years of experience
- In-house support team
- SaaS solutions made in Germany
- European data centers
- GDPR compliant
- Audited by our customers regularly
- Designed and validated in compliance with GAMP&GxP principles
Get to Know Our Solutions
MedTech
mytracekey UDI Manager
Pharma
mytracekey PHARMA
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.
tracekey Knowledge Base
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.
MedTech
Small and medium-sized enterprises (SMEs) often struggle with the complexity of the Medical Device Regulation (MDR). A clear UDI strategy can help standardize processes and ease the regulatory burden. […]
Pharma
Despite the ongoing war, there are efforts to advance pharma serialization in Ukraine and thereby improve patient safety. The serialization guidelines were adopted by the Cabinet of Ministers on September 26, 2024 […]
Other topics
Small and medium-sized enterprises (SMEs) often struggle with the complexity of the Medical Device Regulation (MDR). A clear UDI strategy can help standardize processes and ease the regulatory burden. […]
About tracekey
At tracekey, it is important that our employees organize their lives outside of work well. Especially for those who take care of children or other relatives, we want to offer […]