Consulting

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.

28.05.2026

When FMEA meets AI
Why isolated silos create audit risks

What exactly is the failure mode that your FMEA is supposed to describe if a neural network detects pedestrians? Explain why traditional safety methods reach their limits when applied to in-vehicle AI.

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.

23.04.2026

Hybrid Diagnosis-Related Groups (Hybrid DRG)
Hospital IT faces the test of cross-sectoral integration

Starting in 2026, approximately one million cases that were previously classified as inpatient will be covered by the Hybrid DRG system. Learn what this means for the IT architecture of hospitals and medical care centers and why now is the right time to rethink interface landscapes structurally.

31.03.2026

“Deutschland-Stack” for government IT
What “DevSecOps only” actually means

In March 2026, the German IT Planning Council adopted the “Deutschland-Stack”. One of its core principles is “DevSecOps only.” Read on to learn what this decision means for development and testing processes in German government agencies and how you can get started today.

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.

14.03.2026 by Matthias Lutz

NIS-2: More than 18,000 companies are missing from the BSI portal. What’s behind this?

Over 18,000 companies missed the NIS-2 registration deadline with the BSI. The cause is often not negligence, but rather a capacity issue. What to do now.