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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.
Intended use / intended purpose.
Regulations, guidance and standards.
Bias and trustworthiness.
Machine Learning Medical Device (MLMD) Training.
Monitoring and mitigation.
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