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

Aug 3115 min read

Why RFK jr. reshaping US FDA into an information only authority is not bad although it is.

DALL-E generated Robert F. Kennedy Jr.'s proposed reorganization of the Food and Drug Administration (FDA) envisions a groundbreaking...

Rudolf Wagner

Mar 53 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...

SaMD

Rudolf Wagner

Feb 25 min read