Global frameworks offer valuable insights for Europe as the region is currently working to refine its regulatory systems. While Europe is a significant player in the medical device market, the MDR ...
As the world contends with a growing number of extreme weather events and global shipping routes are increasingly impacted by geopolitical strife, supply chain challenges have surged. Thus, ...
The FDA’s final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions (AI-DSFs) has arrived, replacing the draft guidance issued in April 2023. While the ...