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Digital Guide and Supporter, AI and Software in Healthcare,
Regulatory, Quality, Compliance and Policy.
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Beitrittsdatum: 13. Aug. 2024
Beiträge (2)
5. März 2025 ∙ 3 Min.
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...
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2. Feb. 2025 ∙ 5 Min.
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...
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