[Yakup] C&R Research, Successfully completed US FDA medical device 510(k) approval work
C&R Research (CEO Moon-Tae Yoon) successfully carried out the US FDA medical device 510(k) approval work, expanding business scope to include not only pharmaceutical clinical trials but also medical devices.
According to C&R Research, its related company Trial Informatics received US FDA 510(K) approval for its product ‘Aid-U’. The U.S. FDA medical device 510(k) approval comprehensively evaluates product verification, data validity, manufacturing process, and safety to prove substantive equivalence to a predicate device that is legally distributed in the U.S., meaning permission to sell the product.
