Stakeholders’ engagement is needed to contribute to project success and customer satisfaction from the start to the end of the project; it helps to enable success in each phase. The design Development...

The DHF should be treated as an essential asset for quality control of the design controls process since it is the set of documents ensuring compliance with regulatory requirements to support continuo...

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...