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BioPhia consultants have routinely been invited to give presentations or write articles on key issues in the biopharmaceutical field.

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

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 is now regulated by the FDA Center for Devices and Radiological Health (CDRH). FDA partnered with regulatory authorities from other countries/regio

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5 days ago1 min read