The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device ...
On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” ...
Tell us about the control strategy you've implemented with AstraZeneca and its external partners. Over the last year, we worked to improve our control strategy for drug delivery devices. Our goal was ...
Identify and address the critical questions that consistently impact automation project outcomes across diverse industries like food processing, pharmaceuticals and transportation. Learn technical ...
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