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    • Whitepaper
      Medical Devices

    AI Machine Learning and Medical Devices

    This paper will examine the issues associated with the use of Artificial Intelligence / Machine Learning (AIML) in medical devices.

    Methods and guidance on addressing safety

    This paper will examine the following issues associated with the use of Artificial Intelligence / Machine Learning (AIML) in medical devices.

    • Beoogd gebruik/beoogd doel.

    • Voorschriften, richtsnoeren en normen.

    • Vooringenomenheid en betrouwbaarheid.

    • Training machine learning medische hulpmiddelen (MLMD).

    • Monitoring en risicobeperking.

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