eQMS 'QMSmart' for Medical Device Manufacturers Wins 'The Absolute Best' Grand Award at the 101st Japan Society of Medical Devices Conference Medical Show Japan & Business Expo 2026

Berry Inc. (Headquarters: Taito-ku, Tokyo; Representative Director: Yuji Nakano), a medical device manufacturer, is pleased to announce that its eQMS software 'QMSmart (QMSmart)' has received the Grand Award 'The Absolute Best' at the 101st Japan Society of Medical Devices Conference Medical Show Japan & Business Expo 2026, hosted by the Japan Society of Medical Devices on June 5, 2026.

This award is the highest honor presented by the conference chair, recognizing the most advanced and impactful exhibitions and initiatives that contribute significantly to improving medical device safety and quality, enhancing operational efficiency in healthcare settings and member companies, and driving the future development of the medical device industry.

■ Selection Rationale

The Japan Society of Medical Devices, the organizer, provided the following evaluation for the selection:

The company was highly commended for developing and presenting an innovative eQMS software that streamlines quality management operations for member companies, based on the rigorous quality control system cultivated through its own manufacturing of infant cranial correction helmets. It is not merely a system provider; rather, it delivers a highly effective solution grounded in the practical perspective of a manufacturer. This solution significantly contributes to advancing quality management systems and improving operational efficiency across the entire medical device industry, leading to its selection for the Grand Award 'The Absolute Best'.

■ Statement on the Award

Moving forward, we will continue to uphold our purpose of 'realizing a society where everyone can access necessary medical care when needed,' leveraging our perspective as a medical device manufacturer to contribute to improving the quality and safety of medical devices and enhancing operational efficiency in healthcare settings.

■ Award Overview

Award Name

Grand Award 'The Absolute Best'

Organizer

Japan Society of Medical Devices

Conference Name

101st Japan Society of Medical Devices Conference Medical Show Japan & Business Expo 2026

Award Date

June 5, 2026

■ Key Features of QMSmart

1. Document Management

Digitizes all documentation—from regulations and SOPs to records such as complaint handling forms. Instant access to required information via keyword search. Complies with regulatory requirements through electronic signatures, user permission management, and audit logs.

2. Quality Event Management

Centrally manages quality events such as CAPA, deviations, complaints, and internal audits on the cloud. Progress status, related records, and history of various events are instantly visible. Flexible event templates support all types of quality events.

3. Training Management

Centralizes training planning and attendance tracking linked to document revisions. Significantly reduces training workload through automated online test grading and attendance monitoring. Training records for each participant can be easily verified.

4. AI-Powered Support Functions

AI Regulatory Check for Documents: Automatically checks compliance with regulations such as QMS Ordinance and ISO 13485. Automated Root Cause Analysis: Deeply investigates root causes based on quality data such as complaints and historical similar cases. Automated Online Test Generation: Automatically generates online test questions from documents, significantly reducing time spent creating training materials.