Generally, when planning, project teams have a broad picture of the goal or process in aim but typically forget the sudden risks found during the deve...

Stakeholders’ engagement is needed to contribute to project success and customer satisfaction from the start to the end of the project; it helps to en...

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 complianc...

Regulatory compliance requires a supportive leadership system that brings along a functional structure in a hierarchical manner to promote quality con...

Since insufficient data can't provide detailed information and reliability that the treatment for diagnosis of rare diseases is effective, one challen...

One regulatory challenge in developing medical technologies with AI is exploring real-world data in clinical practice. As technology is evolving quick...