Berry Co., Ltd. is a medical device manufacturer that produces and sells cranial shape correction helmets for babies (Class II medical devices). We provide an app that makes it easy to record and manage helmet treatment, as well as an information platform to support medical device manufacturers in addressing regulatory compliance and QMS (Quality Management System) challenges. Additionally, we offer an AI-equipped eQMS developed to solve issues in QMS operations, aiming to contribute to the advancement of medical device manufacturers and, ultimately, the medical device industry through the digitalization of QMS.