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