[Introduction to Medical Device Safety Standards Webinar 2026] 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

I want to know about this! Cybersecurity standards for medical devices IEC 81001-5-1.

In domestic medical device regulations, comprehensive cybersecurity measures will be required starting April 2024. As a result, understanding and addressing security risks will be essential for the development of new products. This on-demand webinar will introduce the standard for cybersecurity in medical devices, IEC 81001-5-1, through a dialogue format with security experts, explaining terms and concepts. We hope this will help you understand the content of cybersecurity standards. The content is designed to address the specific interests of those responsible, blending perspectives on security and medical devices to be practically useful. --- For those who find security terminology difficult or the intent of the standards unclear, we will explain several key terms. This on-demand webinar will not be in a lecture format but will proceed through a dialogue between the questioner and the explainer. *For viewing methods and details, please refer to the PDF document "【On-Demand Webinar】 Cybersecurity for Medical Devices" or feel free to contact us.*

• Contract Inspection
• Other security
• Public Testing/Laboratory

Response to Brazil INMETRO

To sell medical devices in Brazil, product registration with ANVISA is required. However, before registering with ANVISA, you must demonstrate the conformity of the relevant products based on the INMETRO conformity assessment program. We have summarized the key points of the latest Ordinance No. 384 and the certification process concisely, so please access the "Related Links" below to assist you when considering entry into the Brazilian market.

• Public Testing/Laboratory
• Other Testing Contract

[Speaker] Masashi Sugita, President and CEO of LEX Style Co., Ltd. [Key Lecture Content] The power consumption of AI servers used in data centers has significantly increased, making traditional air cooling insufficient for operation. This lecture will organize the requirements for introducing a liquid cooling system into air-cooled data centers and explain the implementation method using free cooling with specific design details. When handling high-density AI servers, energy efficiency is required, and the widely used energy efficiency indicator, as well as the Ministry of Economy, Trade and Industry's Resource and Energy Agency's PUE regulation of "1.3 or below," will be explained along with practical operational insights. [Lecture Items] 1. Heat dissipation methods for high-density, high-heat AI servers 2. Basics and importance of PUE/pPUE 3. PUE regulation of "1.3 or below" by the Ministry of Economy, Trade and Industry's Resource and Energy Agency 4. AI server implementation and requirements for new data centers 5. Summary and future outlook 6. Q&A / Business card exchange

[Key Lecture Content] 1. Promotion of SAF Introduction Yasushi Yamashita, Director, Carbon Neutral Promotion Office, Aviation Bureau, Ministry of Land, Infrastructure, Transport and Tourism 1. Importance of SAF in the decarbonization of the aviation sector 2. Initiatives to promote the introduction of SAF 3. Q&A / Business card exchange 2. Japan Airlines' Challenge Towards Net Zero CO2 Emissions by 2050 Kazuki Hirotani, Group Leader, GX Planning Group, Sustainability Promotion Department, Japan Airlines Co., Ltd. 1. Introduction of our five initiatives for CO2 emission reduction 2. Initiatives for reducing fuel consumption (introduction of fuel-efficient aircraft, operational improvements) 3. Initiatives for fuel transition (sustainable aviation fuel SAF) 4. Initiatives for reductions outside the value chain (carbon credits, new removal technologies) 5. Initiatives to deepen collaboration with society 6. Q&A / Business card exchange

[Instructor] Yuichiro Kabushiki, Partner Lawyer at TMI Comprehensive Law Office [Key Lecture Content] With the spread of AI, there is growing attention on the civil liability of developers, providers, and users of AI. The Ministry of Economy, Trade and Industry will publish "Guidelines on the Interpretation and Application of Civil Liability in AI Utilization" in April 2026, and the Ministry of Justice will also establish an expert meeting to examine civil liability related to unauthorized use of images and voices generated by AI in the same month. As the full enforcement of the AI Promotion Act and the revision of AI guidelines are underway, it is necessary to design and operate governance based on the potential responsibilities that may arise retrospectively. In this seminar, based on the guidelines from the Ministry of Economy, Trade and Industry and drawing on litigation practice experience as a judge and lawyer, we will organize the basic framework for assessing civil liability and explain fundamental methods for designing and operating governance based on risk analysis. Furthermore, we will examine the framework for civil liability and the design and operation of governance using hypothetical cases that are likely to pose practical issues.

In this seminar, we will welcome Mr. Satoru Hayami from Waseda University, who will explain the latest trends in AI utilization in manufacturing, as well as the evolution of technologies such as agent-based AI and physical AI, and the opportunities and key points for practical application in the manufacturing industry. Furthermore, Mr. Tsubasa Shibata, representative of Next Opt, will introduce processes aimed at practical implementation, incorporating actual case studies from manufacturing sites. We hope you will envision the "potential for AI utilization in your company" and take home hints that will lead to improvements in your operations starting tomorrow. We look forward to your participation.

☆ Date and Time ☆ Ongoing until August 31, 2026 (Monday) 　　https://www.nttd-bb.com/event/smn20260831c.html?utm_source=ipros&utm_medium=other&utm_campaign=20260625_sales ☆ Venue ☆ Online Seminar, Free Participation Fee ☆ Seminar Content ☆ 　Are you manually executing WinActor scenarios every time? 　This seminar is for customers like you! 　In fact, by utilizing the Windows standard feature "Task Scheduler," 　it is possible to automate the execution of scenarios! 　In this seminar, we will clearly introduce how to automatically execute WinActor scenarios at scheduled times. 　The content is designed to be approachable even without specialized knowledge, 　making it a recommended seminar for those who want to improve daily operations! <Target Audience> ・Those who want to deepen their knowledge of WinActor 　・Those who wish to automate scenario execution 　・Scenario creators without programming or system development experience