2. July 2025
Why Professional Support in Writing Scientific Documents for Technical Documentation Is Helpful
4. June 2025
Artificial intelligence in medical devices offers great potential – and new obligations.
Discover how the EU AI Act impacts MedTech companies and what it takes to implement AI systems that are safe, compliant, and future-ready.
4. June 2025
Understanding the technical life cycle of AI in medical devices is key to compliance with the EU AI Act. This post explores the stages from development to deployment, highlighting regulatory requirements and best practices to ensure safe and effective AI integration.
2. June 2025
Successful software development starts with solid planning, clean code, and continuous testing. In this post, we share proven tips to streamline your development process, ensure quality, and deliver projects successfully — from gathering requirements to final deployment.
15. April 2025
Regulation 2024/1860 brings fresh momentum to the implementation of EUDAMED.
Learn what’s changing, which modules are affected, and how MedTech companies should prepare for the upcoming deadlines.
30. January 2025
The Medical Device Coordination Group (MDCG) requested scientific advice from the European Medicines Agency (EMA) to re-evaluate the classification of SARS-CoV-2 in the context of in vitro diagnostic medical devices (IVDs).
20. August 2024
AI has the potential to revolutionize healthcare and improve the lives of millions of people - but only if it is used safely and reliably.
19. August 2024
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
29. July 2024
Digital progress does not stop at medical devices. Read here how you can protect yourself, your product and your software.
12. July 2024
In diesem Beitrag möchten wir Ihnen die Antworten unseres Experten Prof. Michael Imhoff auf die viele spannende Fragen unserer Kunden präsentieren
5. April 2024
Japan is the second largest market for medical devices in the world and offers manufacturers a lot of potential. However, product approval there is a particular challenge.
2. April 2024
In recent years, South Korea has increasingly become an important market for medical devices. The requirements vary in this regard.