Berry Official site

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) will exhibit at the "29th Monozukuri World [Osaka]" (Booth Number: 17-7) to be held from October 7 (Wednesday) to 9 (Friday), 2026, at Intex Osaka Halls 1-6 (Suminoe-ku, Osaka). At the booth, we will conduct a live demonstration of our cloud-based eQMS 'QMSmart' for medical device manufacturers. This exhibition is the largest manufacturing industry exhibition in Western Japan (according to the organizer), hosted by RX Japan LLC. Companies from around the world dealing with IT, DX products, components, equipment, devices, and measurement products will exhibit, facilitating business discussions with representatives from various sectors of the manufacturing industry. It consists of 12 specialized exhibitions, including the "Healthcare and Medical Device Development Exhibition," with an expected 1,100 exhibitors and 31,000 attendees. QMSmart is an eQMS developed by Berry to address the "limitations of paper management" and the "high costs of existing eQMS" faced in our own medical device manufacturing and sales operations. With an easy-to-implement pricing structure starting from 100,000 yen per month and user-friendliness enhanced by AI, it supports the resolution of issues related to the personalization of QMS operations and the shortage of personnel faced by startup and small to medium-sized medical device manufacturers.

Berry Co., Ltd. will exhibit at the "22nd Medical Device Design and Manufacturing Exhibition Medical Creation Fukushima 2026" (Booth Number: D-49) to be held at Big Palette Fukushima from October 1 to 2, 2026. This exhibition is one of Japan's leading business meetings focused on the design and manufacturing of medical devices, organized by Fukushima Prefecture and the General Incorporated Foundation Fukushima Medical Device Industry Promotion Organization. This year, the 22nd edition will see participation from 282 companies and organizations, with over 4,000 expected attendees including design, development, production technology, and procurement personnel from medical device manufacturers. At the Berry booth, a live demonstration of the cloud-based eQMS 'QMSmart' for medical device manufacturers will be conducted. QMSmart is a system developed in-house to address the challenges of "the limitations of paper management" and "the high costs and difficulty of existing eQMS" faced in the medical device manufacturing and sales field. By utilizing AI for user-friendliness and offering an easy-to-implement pricing structure, it supports startup and small to medium-sized medical device manufacturers in overcoming management challenges such as the personalization of QMS tasks and workforce shortages.

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.