[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

We would like to express our congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will be showcasing a number of products, including our new product, the Packaging Container Air Leak Test (Pin Hole Inspection) Device | MSQ-2003 series. We sincerely apologize for the inconvenience during your busy schedule, but we would like to cordially invite you to attend this event. 【 Trade Show Name 】 【 Dates 】 【 Venue/Booth Number 】

[Lecture Topics] 1. Trends and Business Opportunities in Japan's Expanding Energy Storage Industry Koichiro Danno, Principal and Head of Social and Policy Design Unit, Research and Consulting Division, Japan Research Institute, Inc. 1. Background Necessitating Energy Storage Business 2. Behind the Meter (BTM) Business and In Front of the Meter (IFM) Business 3. Trends in Japan's Energy Policy Related to Energy Storage 4. Current Revenue Models in Japan 5. Verification of Profitability in Energy Storage Business 6. Summary 7. Q&A 2. Expansion of Grid-Scale Energy Storage Business in Europe and Japan and Future Prospects Takayuki Ogawa, Executive Officer, Deputy Head of Business Strategy Division, Japan Kogyo Energy Solutions, Inc. and Executive Director, Nippon Koei Energy Europe B.V. 1. Overview of the Company and Introduction to Energy Business 2. Efforts in Energy Storage Business in Europe 3. Efforts in Energy Storage Business in Japan 4. Role and Importance of Aggregators 5. Challenges and Future Prospects of Grid-Scale Energy Storage Business 6. Summary 7. Q&A

[Speaker] Hideo Yamamoto, President and CEO of DIVE COMPASS Inc. [Key Message] "Consumers will no longer be at the end of the power system." By reconfiguring the energy landscape starting from the "consumer" rather than viewing renewable energy, electricity retail, PPA, storage batteries, EVs, VPP, and DSF as separate businesses, there is potential to create new energy businesses in Japan. This presentation will not only introduce the latest trends in Europe but will also consider future market changes and business opportunities from the perspective of "what can be commercialized next in the Japanese market." [Presentation Items] 1. Why consider the electricity market from the consumer's perspective now? 2. Five market changes confirmed at FLEXCON 2026 on the front lines of European DSF 3. The current state of the Japanese DSF market seen through comparison with Europe 4. New consumer-centric energy businesses emerging in Japan 5. Who will hold the connection with consumers by 2030? 6. Q&A / Business card exchange

Are you struggling with the fact that even after raising recruitment costs and hourly wages, on-site personnel are not sticking around? The true causes of turnover lie in "fatigue from heavy labor" and "discomfort in the work environment." However, improving the entire facility or fully automating operations involves enormous initial investments and is not realistic. In this seminar, we will reveal three practical solutions to create a "preferred workplace" based on a case study that reduced investment costs by approximately 20% compared to traditional proposals, without relying on expensive renovations or endless wage increases. The key lies in the integrated design of "construction and equipment" and "robotics." By thoroughly eliminating unnecessary capital investments, we can dramatically reduce the burden on the workforce and enhance productivity. As a company that also engages in outsourcing, we will thoroughly explain the "three principles" that support integrated design, using actual improvement cases. This content is a must-see for executives and site managers who want to fundamentally solve labor shortages within their budgets. [Recommended for] - Companies that continue to face turnover and recruitment difficulties despite raising wages and recruitment costs. - Site managers and executives who considered full building air conditioning or complete automation but abandoned the idea due to high costs. - Site managers and executives who want to balance investment restraint and productivity improvement through relocation or renovations.

We will be exhibiting at the "26th Business Fair" hosted by Seibu Shinkin Bank, which will be held on Thursday, October 15, 2026, at the Triangle Plaza in Shinjuku Sumitomo Building! This event is a corporate exhibition and matching event aimed at expanding business opportunities for small and medium-sized enterprises. Over 300 companies and organizations will participate, promoting their excellent technologies and products to one another.