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Digital Guide and Supporter, AI and Software in Healthcare,
Regulatory, Quality, Compliance and Policy.
Blog & Publications
EU AI Act (2024/1689) and EU MDR (2017/745): Breaking the Expensive Myth: Why AI-Powered Medical Devices Under EU MDR Don’t Need EU AI Act Certification – A Detailed Analysis of Regulatory Requirement
DOI: 10.70317/2025.02rw02 1. Introduction: A Looming Compliance Nightmare or a Simple Fix? With Artificial Intelligence (AI) reshaping...
ADHOCON Info
3. Feb.5 Min. Lesezeit
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Enforcing Software and AI as Medical Devices: Expert Witness Insights on Civil Lawsuits, Regulation, and Legal Liability Pathways
As an expert witness to German courts (Landgerichte, Oberlandesgerichte) and federal courts for Medical Devices and IVDs the number of exper
Rudolf Wagner
20. Okt. 202427 Min. Lesezeit
AI, EHR, SaMD and Hospitals — US, German and Australian regulation make AI immediately available with non-SaMD pathway for Hospitals and Doctors
In the evolving healthcare landscape, hospitals are increasingly developing in-house AI tools and
EHR systems to improve patient care while
Rudolf Wagner
24. Sept. 20245 Min. Lesezeit
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