In June 2015 the Ministry of Food and Drug Safety (MFDS) in South-Korea published a notification with several changes on the medical device act in Korea. Followed by these changes there is a growing awareness of the significance of risks related to the use of medical products. The establishment of a usability engineering process following IEC 62366 is an important method for the investigation and mitigation of such risks.

To get some insights in how to establish the regulatory requirements in the development of new medical devices and the clinical routine a delegation of the Seoul National University Hospital (SNUH) visited Use-Lab. Representatives of the hospital and the Medical Device Clinical Trails Center (MDCTC) together with the Use-Lab team discussed opportunities how to strengthen the cooperation between both parties to successfully fulfill the regulatory requirements.

After China, Malaysia and Japan, Use-Lab is now establishing another strategic partnership in South-Korea for conducting usability studies for the evaluation of intercultural differences in the Asia-Pacific region.Korean Delegation