Medical Device Safety Management Report System 'MEVRS'
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.
- Company:コレオス
- Price:Other