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  4. 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.
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  • Mar 31, 2021
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Mar 31, 2021

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.

コレオス コレオス
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.
Medical Device Safety Management Report System "MEVRS"
Medical Device Safety Management Report System "MEVRS"
Create an XML report that complies with the new format.
Create an XML report that complies with the new format.
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20210331_医療機器安全管理レポートシステム「MEVRS」を販売開始(アシストマイクロ).pdf[231626]

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Medical Device Safety Management Report System "MEVRS"
"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.
Terumo Corporation Adopts BP Director for Process Management of GVP Compliance Operations - Standardizing and Streamlining Safety Management Systems Required for Medical Device Manufacturers After Product Sales
Terumo Corporation has been considering products to IT-enable the processes of approval and administrative reporting that were previously managed on paper. The decision to adopt BP Director was made for three main reasons: the high degree of freedom to realize business requirements without the need for customization, the ability to understand approval status in real-time and view detailed history for traceability management, and the responsiveness of the developer and vendor.

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"Welding repair crack repair" We will repair metal cracks without applying heat.

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The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without causing any thermal impact to the base material. Repairs can be carried out in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If you require a detailed technical explanation, please contact us.

Mar 30, 2026

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Fukuda's leak test, leak inspection, leak detection, leak test, integrity test.

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Fukuda Co., Ltd. has been pursuing leak detection for 60 years and is committed to advancing the future of leak testing. 【 Supporting Various Leak Tests: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing properties. We will propose the appropriate testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the most suitable leak testers for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015)

Mar 30, 2026

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[Cast Prototype] 3D Printer Molding Prototype with Cast Sand Molds

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● The production time for casting prototypes can be shortened! Since model making is not required, the production time for prototypes, which previously took about a month, can be significantly reduced. ● Model costs can be reduced! By directly creating sand molds from 3D data, there is no need for model production costs. If changes to the model are necessary, they can be addressed by modifying the 3D data. ● Similar products with different shapes and dimensions can be prototyped simultaneously! Different products, such as similar shapes or variations in dimensions, can be created in a single molding process. This allows for the verification of multiple types in a short period.

Mar 27, 2026

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Casting prototype and casting repair.

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The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without affecting the base material with heat. Repairs can be carried out in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.

Mar 27, 2026

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Realizing strict access control with high-speed facial recognition and impersonation prevention using edge AI.

High-speed facial recognition and spoof prevention using edge AI enables strict access control management, with FaceMe Security supporting VIA Technologies' access control device "ACS-5000."

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This time, the ACS-5000 is available as a facial recognition terminal compatible with FaceMe Security's add-on feature "Face Terminal," enabling access control management that combines "advanced anti-spoofing features" with high-speed facial recognition powered by edge AI. ■ Main Features 1. Accelerated Authentication Processing FaceMe Security is optimized for the MediaTek Genio 700's NPU, achieving faster facial recognition processing and reduced CPU load compared to processing solely on the CPU. It ensures stable authentication without delays even during peak times such as clocking in and out, contributing to alleviating congestion. 2. Advanced "Anti-Spoofing" Optimized for the IR + RGB camera mounted on the ACS-5000, it can quickly detect fraudulent authentication using photos, videos, or 3D masks within 0.6 seconds, ensuring reliable identity verification. 3. Door Control Without Additional Equipment FaceMe Security can directly control the digital I/O of the ACS-5000, allowing for the construction of an access control management system without the need for additional equipment. This simplifies system configuration and reduces implementation costs.

Mar 27, 2026

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