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AI-powered quality processes are no longer just a fad, but they aren’t a revolution either. Why the foundation matters—and what that means in concrete terms for…

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Why human oversight of AI in medical devices is more than just a UI feature and what the AI Act specifically requires.

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In the medtech industry, data governance determines whether AI succeeds or fails. Why data quality, documentation, and monitoring are becoming regulatory…

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The EU AI Act makes AI compliance in MedTech more complex. Why separate MDR and AI Act strategies fail and how integrated compliance works.

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Many AI projects in MedTech fail not because of the technology, but because of architecture, data and regulation. Why successful AI needs more than good models…

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With the EU AI Act and the MDR, MedTech manufacturers are facing a new regulatory reality: Artificial intelligence must not only be powerful, but also…

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Artificial intelligence promises efficiency, precision and completely new business models. The technology works, models are getting better, data platforms more…

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Why is GenAI not a sure-fire success in medical technology? Generative AI (GenAI) and large language models (LLMs) such as ChatGPT are rapidly moving into…

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With the Second Ordinance Amending the Digital Health Applications Ordinance (DiGAV), in force from February 1, 2026, the legislator has fundamentally developed…

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The FDA provides new clarity: wearables and wellness apps are to be less strictly regulated. For manufacturers, start-ups and tech players, this means more…

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A robot that operates with millimeter precision while an AI calculates the next step: This is not a dream of the future, but reality. In an ageing society with…

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