Regulatory compliance requires a supportive leadership system that brings along a functional structure in a hierarchical manner to promote quality control in the PDCA cycle as a reassurance of the nat...

Since insufficient data can't provide detailed information and reliability that the treatment for diagnosis of rare diseases is effective, one challenge for patients is insurance coverage. Another pit...

One regulatory challenge in developing medical technologies with AI is exploring real-world data in clinical practice. As technology is evolving quickly, regulatory agencies have an urgency to be proa...