Regulatory Affairs

The EU AI Act in 2026
What every company using AI software needs to know now

The EU AI Act is the world’s first comprehensive AI law, and it impacts many more companies than most people realize. Here’s an overview of risk levels, deadlines, and affected industries.

How to secure AI systems: Why traditional testing is not enough

AI software behaves fundamentally differently from traditional applications. Those who test it using conventional methods risk blind spots in audits and approvals. Which approaches will make a difference in 2026?

Homologation: Why certification determines market success or failure

No market access without valid homologation: The certification process determines the success or failure of vehicles and medical devices. Learn why many companies underestimate this critical step—and how you can avoid delays and additional costs.

Cyber Resilience Act and AI in medical technology
Implementing product safety in practice

How AI is changing product development and what the Cyber Resilience Act requires for secure software in medical technology. With practical frameworks, risks, and measures.

Preparing for the EU Cyber Resilience Act
What your company needs to consider now