Berry List of News Articles

Berry Co., Ltd. (Headquarters: Taito-ku, Tokyo; CEO: Hiroshi Nakano) has released "U.S. FDA Information" on the medical device QMS and regulatory media "Pharmaceutical Regulatory Information Navi," which allows users to search approximately 3 million pieces of information, including recall information, adverse event reports (MAUDE), and Warning Letters published by the FDA. Medical device manufacturers need to understand recalls, adverse events, and regulatory issues related to their products and similar devices overseas to enhance their development and quality management. However, such information is dispersed across multiple data sources like openFDA and fda.gov, making it difficult to investigate without knowledge of the U.S. medical device classification system. "U.S. FDA Information" is a service that organizes information published by the FDA in a way that is easy for Japanese regulatory and quality assurance personnel to investigate. Users can search for the U.S. medical device classification (Product Code) from device names in Japanese and English, and check recall information and adverse event reports. It is designed to allow efficient investigation of cases related to their products, even for those who are not familiar with the FDA's complex data structure.

The advancement of AI and digital health has led to a rapid increase in the entry of Software as a Medical Device (SaMD), including diagnostic support AI and therapeutic applications. On the other hand, there are many software-specific issues, from the initial judgment of whether it qualifies as a medical device to drug approval applications and the establishment and compliance investigation of Quality Management Systems (QMS). Businesses originating from IT and software companies often find themselves at a standstill, unsure of where to start. In this seminar, Yuki Hasegawa, who has experience in regulatory affairs, quality assurance, and obtaining business licenses at several foreign medical device and in vitro diagnostic manufacturers, and who currently provides extensive support for the establishment of regulatory and quality systems for medical device and in vitro diagnostic manufacturers, will speak. The seminar will systematically explain the definition and classification of program medical devices, the thought process for judgments based on medical device applicability guidelines, specific points related to SaMD in approval and certification applications, and the perspectives confirmed during QMS compliance investigations.

As a major update, we will enhance AI quality event analysis that accompanies everything from root cause analysis to CAPA planning, full-text search using AI-OCR, and IP address restrictions. Berry Co., Ltd. (Headquarters: Taito-ku, Tokyo; CEO: Hiroshi Nakano) will start providing updates for its cloud-based eQMS "QMSmart" for medical device manufacturers from August 10, 2026. The core of this update is the enhancement of "AI chat," which answers based on the documents, records, and quality events of the implementing companies, and "AI quality event analysis," where AI accompanies everything from root cause analysis to CAPA planning. Additionally, we will simultaneously improve the utilization and control of QMS data through enhanced full-text search using AI-OCR and organizational-level "IP address restrictions."

Berry Inc. (Headquarters: Taito-ku, Tokyo; CEO: Hiroshi Nakano) will hold a free online seminar titled "Evolved with AI! - A Comprehensive Explanation of eQMS 'QMSmart' from Basics to Latest Updates," which will explain the overall picture and latest updates of the cloud-based eQMS "QMSmart" with a live screen demo, on August 21, 2026 (Friday) from 14:00 to 15:00. This seminar is aimed at those considering the introduction of eQMS, as well as quality assurance, design development, and manufacturing personnel at medical device manufacturers who feel limited by paper and Excel-based QMS operations, as well as management. Participants will be able to see the evolved QMSmart in its entirety in one hour, following this summer's major update.