Berry Inc. is a medical device manufacturer whose mission is "to realize a society where everyone can receive the medical care they need, when they need it." Through the development, manufacturing, and sale of "Baby Band," a cranial remolding helmet for infants, the company has put medical device quality management into practice firsthand at its own operations.
That experience gave rise to "QMSmart," an eQMS that streamlines quality management system (QMS) operations for medical devices using AI and the cloud. By centralizing cumbersome QMS tasks—such as document control, quality event management, and training—on the cloud, it helps medical device manufacturers tackle challenges like over-reliance on individual expertise and staffing shortages. As "an eQMS developed by a manufacturer itself, built from a hands-on, on-the-ground perspective," it is used by a wide range of medical device makers, from startups to small, mid-sized, and large enterprises.
A couple of notes on choices I made: I kept "Baby Band" and "QMSmart" in quotes as product names, and rendered 頭蓋形状矯正ヘルメット as "cranial remolding helmet," which is the standard industry term in English. If you'd prefer "cranial orthosis" (the more clinical term) or a different name format, let me know and I can adjust.