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
Authorized Representatives (ARs) carry significant responsibility toward their clients and actively contribute to traceability and product safety through collaboration with stakeholders such as importers. In this FAQ, we clarify responsibilities under MDR and […]
Pharma
The Supply Chain Due Diligence Act (LkSG), commonly referred to as the Supply Chain Act, was passed in 2021 and came into force in Germany in 2023. Since 2024, companies with more than 1,000 employees […]
Other topics
This year, we celebrated the ten-year anniversary of two employees. Both have been with us almost since the founding of the company in 2013 and have significantly shaped its development. […]
About tracekey
This year, we celebrated the ten-year anniversary of two employees. Both have been with us almost since the founding of the company in 2013 and have significantly shaped its development. […]