20. August 2025
Cybersecurity for connected medical devices: meet MDR, NIS2 & FDA requirements, minimize risks, and protect patient safety in 2025.
2. July 2025
Why Professional Support in Writing Scientific Documents for Technical Documentation Is Helpful
27. June 2025
Usability engineering for medical devices: Important regulatory requirements, IEC 62366, UX aspects, and best practices for safe, effective designs.
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.
8. April 2025
The EU Product Liability Directive 2024/2853 modernizes liability law for manufacturers, importers, and distributors – introducing new obligations, risks, and opportunities!
28. March 2025
Medical devices and medicinal products – a bitter pill to swallow? Impact of the MDR on “medical devices with medicinal products as an integral part.”
19. March 2025
In Vitro Diagnostics manufactured and used within EU Health Institutions – In-House Devices (IH-IVD)
In-house IVD: in-house laboratory tests for safe and reliable diagnostics. Find out more about requirements and regulatory specifications!
7. March 2025
The areas of usability engineering, risk management, and design control are closely linked and overlap in some of their objectives and requirements.
20. February 2025
In vitro diagnostics (IVDs) enable early disease detection & precision treatment. Learn how PCR, AI & lab tests improve healthcare & patient outcomes!