Steven Meadows

  • Why Your Medical Device Risk Management is NOT Effective

    Why Your Medical Device Risk Management is NOT Effective

    Medical Device Risk Management Medical device developers must ensure risk is addressed as a core activity. The ISO 14971 standard, which has been revised three times, provides a proven and...

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  • Regulatory Shift for Machine Learning in Software as a Medical Device (SaMD)

    Regulatory Shift for Machine Learning in Software as a Medical Device (SaMD)

    Machine Learning in Software as a Medical Device Machine learning (ML), a subset of artificial intelligence, has become integral across software in all industries, and the medical and life science...

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