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 continuous improvement of design controls. At the same time,…   Read more»

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 nature of the project. First, coordination is needed to improve…   Read more»

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 pitfall of the Human Device Exemption is bypassing the rigorous regulations established by…   Read more»

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 proactive with guiding principles to promote safety and efficacy in the development…   Read more»