Incorporating AI/DP into clinical trials can have a transformational effect on the true clinical value of quantitative biomarkers, but may require a change of paradigm in the way clinical trials are designed. AI/ML medical device manufacturers need to keep abreast with changes in regulatory requirements and feed those into their quality systems and design activities in a timely manner. Internationally, the IMDRF/AIMD Working Group, IEEE P2801 Artificial Intelligence Medical Device Working Group and ISO/IEC JTC1/SC42 Artificial Intelligence Committee are establishing AI/ML guidance and standards. In Europe, with IVDR/MDR, there are no harmonized standards specifically for AI/ML devices, however, Notified Bodies are participating in white papers discussions.
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