Utilizing AI to digitize documents, education, and quality events in a seamless manner!
"QMSmart" is a cloud system created by medical device manufacturers from a field perspective. With specialized AI, it assists in automatic checks for regulatory compliance of documents, creation of educational tests, and root cause analysis. It enables the transition from person-dependent management using tools like Excel, preventing oversight and expiration, thus achieving operational efficiency. 【Features】 ■ All documents and records are digitized, making revisions and approvals smooth ■ Visualizes and automates management of the progress and deadlines of quality events ■ Links education to SOP revisions and automatically accumulates training records ■ AI automatically checks compliance with regulations such as QMS ordinances ■ Automatically generates test questions for training ■ AI supports root cause analysis from quality information such as complaints *For more details, please download the PDF or feel free to contact us.
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basic information
【Regulatory Compliance (Partial)】 ■Compliance with 21 CFR Part 11/ER/ES guidelines ■Audit Trail ■Electronic Signature ■Acquisition of ISO 27001/ISMS certification ■Access Control ■Free provision of CSV (Validation) *For more details, please download the PDF or feel free to contact us.
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Berry Co., Ltd. is a medical device manufacturer that produces and sells cranial shape correction helmets for babies (Class II medical devices). We provide an app that makes it easy to record and manage helmet treatment, as well as an information platform to support medical device manufacturers in addressing regulatory compliance and QMS (Quality Management System) challenges. Additionally, we offer an AI-equipped eQMS developed to solve issues in QMS operations, aiming to contribute to the advancement of medical device manufacturers and, ultimately, the medical device industry through the digitalization of QMS.
