Approval policies for modifications to machine learning‐based software as a medical device: A study of bio‐creep (Q6094186)

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scientific article; zbMATH DE number 7747548
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Approval policies for modifications to machine learning‐based software as a medical device: A study of bio‐creep
scientific article; zbMATH DE number 7747548

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    Approval policies for modifications to machine learning‐based software as a medical device: A study of bio‐creep (English)
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    9 October 2023
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    AI/ML-based SaMD
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    alpha-investing
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    gate-keeping
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    group-sequential
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    online hypothesis testing
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