コレオス Company Profile

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. *Please download for more details.