Validation / Regulatory Affairs

05.03.2026

Artificial intelligence, Automotive Consulting, Consulting, Future Fintech, Future Healthcare, Future Mobility, Healthcare and MedTech Consulting, Industries, Validation / Regulatory Affairs

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

Artificial intelligence, Consulting, Validation / 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.

16.02.2026

Artificial intelligence, Consulting, Validation / Regulatory Affairs

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

Automotive Consulting, Consulting, Cybersecurity, Engineering, Future Mobility, Industries, Software Test, Validation / Regulatory Affairs

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

Automotive Consulting, Automotive SPICE®, Consulting, Engineering, Future Mobility, Industries, Software Test, Validation / Regulatory Affairs

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

Automotive Consulting, Consulting, Future Healthcare, Future Mobility, Healthcare and MedTech Consulting, Industries, Validation / Regulatory Affairs

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

Artificial intelligence, Consulting, Cybersecurity, Future Healthcare, Healthcare and MedTech Consulting, Industries, Validation / Regulatory Affairs

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

Consulting, Cybersecurity, Validation / Regulatory Affairs

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