Quality Insights

30.07.2026

AI skills in computer science degrees
What matters now

More than 90 percent of students use AI tools. But better results don’t automatically mean more skill. What that means for your next hires, and which skill is becoming the new learning objective at universities.

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.

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.