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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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[Limited Time] Learn how to advance "Realistic DX"! Special event "Monozukuri DX CAMP" for small and medium-sized manufacturing businesses!

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Technoa Co., Ltd. (Headquarters: Gifu City, Gifu Prefecture, Representative Director: Koji Yamazaki) will hold a limited-time summer special event, "Monozukuri DX CAMP," from Saturday, August 9, 2025, to Saturday, August 23, 2025. Small and medium-sized manufacturing companies face challenges such as a shortage of specialized personnel and a lack of know-how and information, which act as barriers to promoting DX (digital transformation). This event will provide a step-by-step approach to "realistic DX," based on the know-how accumulated by Technoa while supporting the DX transformation of small and medium-sized manufacturing companies. It will be structured as DAY.1 to DAY.5, offering an opportunity for skill development during the summer break and supporting the learning and growth of small and medium-sized manufacturers. For more details, please refer to the related link.

Aug 08, 2025

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Solve the challenges of large-scale processing! Updated solution page to achieve high quality and short delivery times.

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JOHNAN has updated a webpage summarizing the selection points to solve various challenges in large-scale processing (quality maintenance, short delivery times, costs). This article introduces the challenges faced in large-scale processing based on years of knowledge and experience, as well as the key points for choosing the optimal contractor that balances quality and short delivery times. If you are looking for a reliable contractor, please make use of our "Large-Scale Processing Solutions." ▼For more details "Large-Scale Processing Solutions to Achieve Product Quality and Short Delivery Times" https://www.johnan.com/solution/process/processing-assembly/post_8.html

Aug 08, 2025

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Notice of Summer Vacation

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Thank you very much for your continued support. We sincerely apologize for the inconvenience, but our company will be closed for summer vacation during the following period. 【Closure Period】 From Saturday, August 9, 2025, to Thursday, August 14, 2025. We will resume normal business operations on Friday, August 15. We appreciate your understanding during this time and apologize for any inconvenience caused.

Aug 08, 2025

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A video introducing the implementation technology for stretchable film has been released.

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JOHNAN has released a video that clearly explains the implementation technology for stretchable films, which are expected to be utilized in wearable devices and medical equipment. In the video, you can see how the film, which has excellent elasticity, stretches and contracts. Please check our high technological capabilities and the flexible characteristics that are useful for product development. We hope this will help you generate new ideas in product development. ▼You can watch the video here [Link to the implementation page for stretchable films] https://www.johnan.com/dms/mounting/filmdevic/stretchable/

Aug 08, 2025

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Checkpoints and Measures for Underfloor Inspection After Typhoons and Heavy Rain

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"Because it's an invisible place, we won't overlook it." Japan's climate is characterized by high temperatures and humidity, and particularly after typhoons and heavy rains, the conditions can be harsh for homes. It's not just the roofs and exterior walls that are affected by rain and wind. The area beneath the floor is actually the most susceptible and often overlooked point. This time, we will explain the "checkpoints for under the floor" that should be confirmed after a typhoon or heavy rain, the "responses" if abnormalities are found, and measures for preventing recurrence. [Table of Contents] ■ Why is underfloor checking necessary? ■ Checkpoints to confirm after a typhoon or heavy rain ■ Responses when damage is discovered ■ Points for preventing recurrence ■ Suggestions from Seihou Products ■ Summary Please be sure to read the [related materials] and [related links]. ↓ ↓ ↓

Aug 08, 2025

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