A cloud system that supports the standardization of medical device safety management operations! It enables the management and review of safety information, creation of XML reports, and automatic sending and receiving with PMDA.
"MEVRS" is a cloud-based system that manages safety management information and reporting tasks related to defects, required of medical device manufacturing and sales companies as part of compliance with GVP ministerial ordinances. It focuses on the basic functionality to create report data in XML format as required by PMDA, supports the centralized management of safety information and the consideration of the necessity for reporting, and also accommodates automatic sending and receiving of report data with PMDA through EDI integration. We support the standardization and efficiency of safety management tasks that our customers require. 【Features】 ■ Create and centrally manage reports using a web browser, with support for audit trails ■ Expand necessary functions when needed, with flexible integration of existing data ■ Start using a validated system smoothly in the cloud, with reliable implementation and operational support *For more details, please download the PDF or feel free to contact us.
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basic information
【Basic Functions (Partial)】 ■ Create reports using a web browser and output report data in the XML format specified by PMDA ■ Bulk import of reporting cases is also possible ■ Implement internal approval from superiors and responsible parties using workflow functionality ■ List each task, manage deadlines with visibility and pre-alert emails ■ Search, view, output, and reuse report data ■ Supports additional reports, withdrawal reports, and periodic reports *For more details, please download the PDF or feel free to contact us.
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Koreos Corporation (formerly known as Assist Micro Corporation) focuses on the important areas of "human resource development" and "business improvement" within organizations. We offer excellent software and comprehensively support our customers in solving the challenges they face and realizing their ideals, from consulting to post-implementation operations and support for establishment, as well as continuous improvement. As an IT partner that stands by our customers' management challenges and walks alongside them, we contribute to your business. [Main products and services offered] Business Process Management System (BPM), Learning Management System (LMS), multilingual online language programs, video creation and distribution management system, reporting management system for medical device manufacturing and sales companies, formula editor, and more.
