Quality Insights

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.

27.05.2026

External software quality assurance in government IT
When and how to outsource?

Skills shortages, NIS-2, and mandatory DevSecOps are presenting IT managers in government agencies with quality challenges that internal teams alone can no longer solve. How to strategically justify and properly tailor external QA contracts.

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?

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.

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.

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.