[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 1: Medical Device Regulations and Safety Standards

Providing solutions for the global market.

UL Solutions provides evaluation testing and certification in accordance with product safety standards and EMC standards, biocompatibility testing, reprocessing validation, packaging validation, and ISO 13485 audit registration services to manufacturers of medical devices, in vitro diagnostic medical devices, laboratory equipment, and testing/measurement equipment.

• Other contract services

Compliance with IEC 60601, IEC 61010, and various individual standards.

Our company is one of the NRTLs (Nationally Recognized Testing Laboratories) recognized by the U.S. OSHA, and we are also a CB accredited testing laboratory certified by IECEE in the fields of medical electrical equipment and in vitro diagnostic medical devices. Additionally, we are an ILAC accredited testing laboratory registered with the International Accreditation Service, Inc. (USA). The evaluation reports and certifications we provide can be used for medical device and in vitro diagnostic medical device regulatory submissions in various countries.

• Contract Inspection

Manufacturers need to demonstrate compliance with regulations regarding safety and performance requirements to ensure product safety and market entry.

Medical device manufacturers need to demonstrate compliance with numerous regulations regarding electromagnetic compatibility (EMC), wireless performance, radio frequency (RF) exposure, and other safety and performance requirements to ensure product safety and market entry. UL Solutions provides comprehensive support and guidance from design concept to product completion, helping to avoid potential issues and reduce time to market.

• EMC Testing
• Contract measurement
• Public Testing/Laboratory

Nitto Kohki will exhibit at the "30th Mechanical Components Technology Exhibition [Tokyo]" held at Makuhari Messe Hall 5 from July 9 (Wednesday) to July 11 (Friday). [Booth Number: Hall 5 31-32] At this exhibition, we will showcase a variety of products, including the electric suction hand "e-VEE" with a built-in pump that does not require compressed air, a cordless belt sander, the electric driver "Delvo" that can be mounted on robots, and the "Flow Monitor" that allows for easy visualization of the flow of cooling water in molds and other applications.

[Key Lecture Content] 1. Opportunities brought by the expansion of investments in AI data centers and strategies that facility equipment vendors should adopt Tomoki Fujimoto, Senior Analyst, Industrial Research Department, Mizuho Bank 1. Overview of the data center industry 2. Challenges surrounding data centers 3. Strategies of competing companies in Europe and the United States 4. Future strategic direction for Japanese companies 5. Q&A / Business card exchange 2. Domestic and international challenges and policy trends regarding data center locations ~Urban, power, and land use strategies in an era of advancing national infrastructure~ Tetsuji Ooba, Professor, Graduate School of Management / Graduate School of Engineering, Kyoto University 1. Data centers becoming national infrastructure 2. Domestic and international challenges regarding data center locations 3. Policy and regulatory trends in major overseas metropolitan areas 4. Location strategies and policy issues in Japan 5. Outlook for business opportunities and future strategies 6. Q&A / Business card exchange

The current Japanese manufacturing industry has entered an era where it cannot survive in a competitive society without engaging in value-added operations within limited human resources and time, which is why the necessity of digital transformation (DX) is being emphasized. In this seminar, we will explain what DX in manufacturing means, covering the following three steps to promote DX for manufacturing companies: 1. First, streamline each operation with a system. 2. Utilize the data obtained through systematization. 3. Eliminate "waste in operations" that becomes visible through data utilization. 【Recommended for those who:】 - Have been told to implement DX but don't know where to start. - Are conducting production-related operations in an analog manner and find it inefficient. - Want to eliminate unnecessary operations on the manufacturing floor but don't know how to proceed.

Recently, "visualization of information" has been attracting attention for the purpose of improving productivity and reducing costs. Various companies are working towards this visualization, but on the other hand, we often hear about the following issues: - We want to achieve visualization, but the necessary data is scattered and not collected. - We have data, but it is not organized in a usable format, making it unusable. Thus, for visualization, it is required not only that "data exists" but also that "data is collected in a usable form." In this seminar, we will introduce methods for proper data collection and organization to achieve visualization through the introduction of "ASTERIA Warp," which enables data integration without coding, and "Dr.Sum," a data utilization platform for companies.

Are you ready to escape the 'manual input hell' of FAX and phone orders? 'Processing 20 orders a day takes over 2 hours' 'Excel data entry work accounts for 40% of daily operations' To all manufacturing companies struggling with such inefficient order processing. In this seminar, we will introduce specific methods for optimizing order processing in three stages, based on case studies of companies that have achieved annual cost reductions of 7.2 million yen and a 78% improvement in error rates. From automatic data conversion of FAX using OCR technology to building a web order system, you will learn practical know-how to eliminate 'manual input hell' through gradual digitalization.