Berry Co., Ltd. (Headquarters: Taito-ku, Tokyo; CEO: Hiroshi Nakano), which operates the specialized media "Pharmaceutical Affairs Information Navi" for medical device QMS and regulatory affairs, has started offering a free download of the white paper "QMS Ordinance Document, Record, and Procedure Checklist (Excel)" for medical device manufacturers. This document lists the documents, procedures, and records required by the QMS Ordinance in the order of the document hierarchy, with the quality manual at the top. Each item includes the article number of the QMS Ordinance and the corresponding item number of ISO 13485:2016, making it directly usable for self-inspection prior to QMS conformity assessments and QMS system ordinance investigations.

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.

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."