Assist Micro has started selling the medical device safety management report system "MEVRS" - Responding to the new format for reporting defects required in the medical device manufacturing and sales industry, promoting efficiency and standardization of GVP operations.

Assist Micro Co., Ltd., which sells overseas software, announces the official launch of its new packaged product "Medical Device Safety Management Report System MEVRS" developed based on a business process management system for which it acts as the general sales agent in Japan. This system supports the management of safety information and reporting of defects as required by the GVP Ordinance, assisting medical device manufacturing and sales companies in their relevant operations.
According to the GVP Ordinance, medical device manufacturers and sellers are obligated to collect various information related to their products, determine the necessity of administrative reporting based on specific criteria, and report the relevant information by the designated deadline. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) manages these reports, but since April 2021, reporting has transitioned to a new format, requiring companies to adapt accordingly.
MEVRS not only generates report data in XML format that complies with this new format but also includes two options: a safety information measure planning function that allows for decision-making on the necessity of reporting and reporting formats using a decision tree, and an EDI integration function for automatic sending and receiving of report information, making it a cloud-based package system.
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"MEVRS" is a system that efficiently operates and manages the reporting of defects and other issues required for medical device manufacturing and sales. It supports the creation of report data in XML format compliant with the new format from April 2021, basic functions for automatic sending and receiving of reports through EDI integration, and optional functions for managing safety information and considering measures prior to reporting, thereby assisting in the efficiency and standardization of GVP-compliant operations.
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