Kuniki IMAGAWA received his Ph.D. in Engineering from the Tokyo City University. He worked at Philips Japan, Ltd. as a regulatory specialist. Since 2012, he has been working in the medical device standards division of the Pharmaceuticals and Medical Devices Agency. His current job is to develop standards or guidelines in pre-market regulation, especially for medical electrical devices and medical device software, and also to participate in the development of IEC and ISO standards. Since 2022, he's also a member of the Office of Software as a Medical Device. In this office, his work focuses on the international activities such as IMDRF of medical device software.