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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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