Dr. Anja Segschneider

The European AI Act and Its Impact on Medical Devices Worldwide

By Dr. Anja Segschneider 20 March 2024 Leave a comment

It’s done. The European Artificial Intelligence Act (AI Act) has finally become a reality. After years of back-and-forth, the time came on 13 March 2024: The European Parliament approved the…

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New FDA Quality Management System Regulation (QMSR): Why Medical Device Manufacturers Need to Prepare Now

By Dr. Anja Segschneider 29 February 2024 Leave a comment

The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) on 2 February 2024 marks a pivotal change, as it updates the Quality…

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