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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.

  • Intended use / intended purpose.

  • Regulations, guidance and standards.

  • Bias and trustworthiness.

  • Machine Learning Medical Device (MLMD) Training.

  • Monitoring and mitigation.

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