Healthcare and MedTech Consulting

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.

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.

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.

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.

26.01.2026

SAP IS-H will be discontinued in 2030: How to future-proof your hospital IT now

SAP IS-H will be discontinued in 2030. What may initially sound like a burden for many hospitals is actually an opportunity to comprehensively modernize healthcare IT and realign digital processes.

04.12.2025

Homologation: Why certification determines market success or failure

No market access without valid homologation: The certification process determines the success or failure of vehicles and medical devices. Learn why many companies underestimate this critical step—and how you can avoid delays and additional costs.

30.10.2025

Cyber Resilience Act and AI in medical technology
Implementing product safety in practice

How AI is changing product development and what the Cyber Resilience Act requires for secure software in medical technology. With practical frameworks, risks, and measures.

17.10.2025

Quishing, smishing, and more
Underestimated gateways into medical infrastructure

Social engineering remains one of the most effective types of attack on hospitals and medical practices. This article analyzes quishing, smishing, and vishing, describes observed scenarios, and derives prioritized protective measures from them.