In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement ...
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” ...
Advanced packaging is transforming semiconductor manufacturing into a multi-dimensional challenge, blending 2D front-end wafer fabrication with 2.5D/3D assemblies, high-frequency device ...
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