Artificial intelligence

23.07.2026

When AI writes the code
What role is left for humans?

Generative AI now takes over entire software components, yet in safety-critical systems, humans remain indispensable. Find out where AI truly speeds up legacy software modernization, and why verification is becoming the new bottleneck.

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.

04.05.2026

AI in software development
Why tools alone are not enough

AI tools have long been adopted by many development teams, yet the expected increase in productivity often fails to materialize. What’s missing between code suggestions and automated workflows, and how can this gap be closed?

22.04.2026

AI in Action
A Look Back at the Afterwork Exchange

How do you establish an AI culture within a company? What does the EU AI Act mean for regulated industries? At the first Afterwork Exchange, "Business Impact: AI,” hosted by sepp.med, decision-makers and experts discussed these questions. The answers were surprisingly concrete.

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.