Quality Insights

06.10.2026

CRA Reporting Obligation (Cyber Resilience Act)
What Really Has to Happen in the First 24 Hours

The CRA reporting obligation has applied since September 11, 2026: early warning within 24 hours, even at the weekend. This article shows what manufacturers need to prepare and provides a process for the first 24 hours to walk through.

29.09.2026

Three AI Tasks in Software Testing That Are Often Mixed Up

The release is scheduled, testing capacity is tight, and AI is writing code alongside your team. Why software testing thereby becomes a sourcing question, and which three AI tasks you should keep apart before deciding between build and buy.

15.09.2026

Building Software Test In-House
The Hidden Bill

Building test capability entirely in-house seems like the obvious choice. But the most expensive items never show up in the business case. Which ones they are, and when buying capacity pays off, is what this article covers.

11.09.2026

The talent pyramid is tipping
Why your most experienced engineers are becoming your team’s scarcest resource

AI makes code cheap, but the review capacity of your most experienced engineers becomes the bottleneck. What recent studies show about the tipping talent pyramid, and what leaders in regulated industries can do about it right now.

20.08.2026

Why 96 percent of developers distrust AI code, but only half of them review it

96 percent of developers distrust AI code, yet only 48 percent actually review it. The reason lies in the flow effect of vibe coding, and in what helps counter it.

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.