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