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Digital Guide and Supporter, AI and Software in Healthcare,
Regulatory, Quality, Compliance and Policy.
Blog & Publications
Analysis of Software as a Medical Device (SaMD) Compliance in App Store Applications: A Critical Review of Regulatory Oversight and App Store Accountability
This report presents a comprehensive analysis of Software as a Medical Device (SaMD) compliance within applications available on the Google Play Store. We analyzed Google Play listings (noting parallel availability on Apple’s App Store where visible) listings observed between 1 April –2 April 2025 (time zone: Europe/Berlin) in the USA and Germany store configuration. Results reflect what was publicly displayed during that time. Our review focused on applications making clinic
Rudolf Wagner
3 days ago15 min read
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...
Rudolf Wagner
Feb 35 min read
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
Oct 20, 202427 min read
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
Sep 24, 20245 min read
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