Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...
Mercury Interactive Corp. today rolled out a new tool designed to allow companies to automate change management and ease the risks associated with application and infrastructure modifications. The new ...
On January 12, 2021, the U.S. Food and Drug Administration (FDA) published the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (action plan) in ...
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