In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
Members can download this article in PDF format. Artificial intelligence (AI) dominates business news these days as companies across a wide range of industries seek to leverage the technology to boost ...
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