Validation / Regulatory Affairs

14.07.2026

AI Act meets MDR
Why a second QMS is the wrong path

The EU AI Act presents SaMD manufacturers with a new reality, even though the Digital Omnibus has pushed the key deadline back to August 2028. Those who make good use of the extra time won’t be setting up a second QMS—they’ll be building a stronger one.

22.06.2026

5 warning signs that your MedTech QMS isn’t ready for the AI Act

Starting in August 2028, the AI Act will require concrete evidence for high-risk AI as product component. However, many medtech QMSs have blind spots. There are five warning signs that indicate whether action is needed and, if so, to what extent.

21.05.2026

As the Operational Design Domain expands, traditional tests fail
SOTIF in automotive practice

An AI system passes all lab tests but still fails in the field. No bug, no programming error: ISO 21448 has a name for this exact phenomenon. What this means for your safety case.

30.04.2026

Validation at its limits?
Why document-heavy CSV is reaching its limits in medical technology

80% documentation, 20% actual testing—that’s what validation looks like in many medtech companies. Why this ratio poses a risk, and what paradigm shift has already begun.

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.