Validation / Regulatory Affairs

24.03.2026

Reasoning AI under scrutiny
How to make explainability verifiable

LLMs that use reasoning explain their answers in natural language. This opens up new possibilities for audits in regulated industries. One prerequisite is that the explanations themselves become part of the quality assurance process.

05.03.2026

The EU AI Act by industry
What distinguishes the medtech, automotive, finance, and administrative sectors?

The EU AI Act affects almost every industry, but not all industries are affected in the same way. What specific obligations apply to the medical technology, automotive, finance, and public administration sectors? Here’s a compact industry comparison.

27.02.2026

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.

16.02.2026

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?

05.02.2026

Securing automotive software: Automation, safety and security

Seit Juli 2024 gelten verschärfte Cybersecurity-Anforderungen für Fahrzeuge. Wie Sie Automotive Software durch Testautomatisierung und integrierte Safety-Prozesse absichern.

15.01.2026

Quality assurance for automotive software: From testing to ASPICE 4.0

Today's vehicles contain over 100 million lines of code. How can quality assurance be achieved with this level of complexity? The first part of our series of articles shows the path from requirements to ASPICE.

04.12.2025

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.

30.10.2025

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.

25.05.2023

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