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Regulatory Path for Artificial Intelligence / Machine Learning (Software as a Medical Device (SaMD))

Updated: Sep 18, 2023





BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the regulatory paths associated with Artificial Intelligence/ Machine Learning or Software as a Medical Device (SaMD).


Software as a Medical Device (SaMD) is a relatively new area of medical devices that are now regulated by FDA (CDER). FDA partnered with regulatory authorities from other countries/regions to create the International Medical Device Regulatory Forum (IMDRF) which is a risk-based approach to determine validation guidance, quality systems, and clinical requirements for SaMD products.

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