Machine Learning Software as a Medical Device: Can We Update Our Model?
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Dr. Oliver Eidel
There is no short answer. It’s a mess and depends on your auditor, that is, if you can reach them. There’s the MDCG 2020-3 guidance document which c
We recently went through a significant change notification for an MDR Class IIb SaMD. Our internal procedure is to notify changes only when significan
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