The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
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 ...
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback