[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

At the Dry Fog Humidification System Free Demo Experience, you will have the opportunity to actually experience our Dry Fog, as well as our single-fluid and dual-fluid humidifiers. We will explain the differences from conventional humidifiers and the effects of implementation. In addition to introducing the latest case studies, we will also provide time for you to consult directly with our specialized staff. Please select a convenient venue and date from the application page and apply. * The "morning session" and "afternoon session" contain the same content. Please participate at a time that suits you. * This event is intended for users only. Participation from trading companies, other companies in the same industry, or for sales purposes to our company is not permitted. Venues: ■ Yamagata Venue: 3/12 (Wed) at Yamagata International Exchange Plaza 3/13 (Thu) at Sakata Chamber of Commerce and Industry ■ Sendai Venue: 3/14 (Fri) at Kiri no Ikeuchi Sendai Branch ■ Tokyo Venue & Osaka Venue: 3/18 (Tue), 3/19 (Wed), 3/21 (Fri) at Kiri no Ikeuchi Tokyo Sales Office & Kiri no Ikeuchi Osaka Headquarters ■ Nagoya Venue & Fukuoka Venue: 4/9 (Wed), 4/10 (Thu), 4/11 (Fri) at Kiri no Ikeuchi Nagoya Sales Office & Kiri no Ikeuchi Fukuoka Sales Office

[Speaker] Mr. Manabu Kamitani, Manager, Performance Unit, Arthur D. Little Japan K.K. [Key Lecture Content] In recent years, both quantum technology and AI have seen technological development and investment at the national level, not just by companies, in various countries. While private enterprises are advancing the verification of the potential and promise of both quantum and AI technologies, the societal penetration of these technologies differs due to the uncertainty of their evolution. This has led to a demand for advanced technological intelligence capabilities that balance the maturity of the technology with expectations for its application in business development and internal implementation based on cutting-edge technologies. This lecture will multifacetedly examine the key points of how to utilize developing advanced technologies, taking into account the current understanding and future direction of quantum technology and AI. [Lecture Items] 1. Current status of the utilization of quantum technology and AI 2. Future development directions of quantum technology and AI and challenges toward realization 3. Considerations for business development and planning for advanced technologies based on the current status and challenges 4. Summary of today's discussion 5. Q&A / Business card exchange

[Speaker] Takayuki Furuta, Director of the Future Robot Technology Research Center (fuRo), Executive Director of Chiba Institute of Technology [Key Lecture Content] The true value of robotic technology lies in its ability to directly impact the physical world, creating tangible value for society, from economic activities to people's daily lives. This lecture will focus on the evolution of robotic technology as a core system that connects cyberspace and the real world, introducing development examples of AI-equipped mobility. Furthermore, while considering the latest trends in robotic technology being utilized in real society, we will explore the future direction and potential of technological development. Additionally, we will indicate the direction that Japan's industry and technology should aim for in the future and reflect on the grand design of society and technology necessary for its realization. [Lecture Items] 1. The essence of robotic technology and its social value 2. The fusion of AI and robotics 3. Development examples of AI mobility 4. How robotic technology is transforming industry and society 5. The grand design of Japan's technology and industry 6. Q&A / Business card exchange *The lecture content may be subject to change based on the latest trends.

[Speaker] Tetsuji Narita, President of NRT Energy Bridge Co., Ltd. [Key Lecture Content] Due to the rapid expansion of AI data centers, the power system is transitioning from "ensuring quantity" to "simultaneous design of reliability, environmental value, and construction period." While the government is taking steps to ensure system capacity in collaboration with watt-bit and in GX strategy regions, on-site, different entities such as DC operators, retailers, power generation and storage, local governments, and transmission companies tend to operate in different languages. This lecture will organize the current state of the system from PPA to practical design of power source portfolios, providing a checklist for each stakeholder and a common language to "operate on the same schedule." [Lecture Items] 1. Overall Overview: Structural organization of how AI DC has become a "design variable" in the power system 2. Current state of watt-bit collaboration and connection discipline 3. GX strategy regions (DC aggregation type): Issues in industrial cluster design 4. Practical design of PPA and power source portfolio 5. Preparation for environmental value and 24/7 CFE 6. Summary: Stakeholder-specific checklist and common schedule 7. Q&A / Business card exchange

[Speaker] Kazuhiro Kaiho, Manager, Environmental, Energy, and Resource Strategy Group, Research and Consulting Division, Japan Research Institute, Ltd. [Key Lecture Content] Decarbonization of automobiles is entering a phase where EVs, hydrogen, and RNG are utilized according to the industrial structure of countries and regions, energy resources such as renewable energy and biomass, and infrastructure constraints, rather than being solely focused on EVs. This presentation will compare the U.S. tax credits, LCFS, and RFS; China's NEV promotion policies and hydrogen demonstrations; and Europe's RED III and AFIR, organizing which fuels each region is aiming to expand for which applications. It will highlight different winning strategies for passenger and commercial vehicles and provide insights for Japanese companies. [Lecture Items] 1. Why is it important to view "automotive fuel policy" through regional comparisons now? 2. United States: Expanding RNG, hydrogen, and low-carbon fuels through market incentives. 3. China: A dual-front strategy focusing on EVs while nurturing hydrogen for commercial vehicles. 4. Europe: Advancing EVs, hydrogen, and renewable gas through regulatory leadership. 5. Insights for Japanese companies: What should Japan learn and how should it proceed? 6. Q&A / Business card exchange.