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  • Services
    • Medical Device Regulatory Consulting
    • Technical Documentation for Medical Devices
    • SaMD Compliance & Software Documentation
    • External PRRC & QMR Services
    • In-Country Representation for Medical Devices & SaMD
    • Micro Consulting for MedTech & SaMD Compliance
  • Training
    • Workshops & Inhouse Training
    • Regulatory Accelerator Programs
    • Startup Office Hours
    • Our Courses
  • About us
  • Resources
  • Contact us
  • FAQs

Monthly Archives: March 2024

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AI Act European Flag

The European AI Act and Its Impact on Medical Devices Worldwide

Regulatory AffairsBy Anja SegschneiderMarch 20, 2024Leave 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 AI Act, albeit with last-minute changes to the final text of the law. This milestone in AI legislation is now official – and the AI…

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