[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

Able to respond to pharmaceutical applications in various countries.

In the field of medical devices, ensuring biological safety with consideration of risk assessment is required, as stipulated in ISO 10993-1. It is necessary to evaluate potential risks, such as toxicity and allergic reactions, to human tissues that come into direct or indirect contact with the medical device. There are various tests, including cytotoxicity tests, irritation tests, sensitization tests, genotoxicity tests, implantation tests, and blood compatibility tests. However, the selection of necessary tests/evaluation items for regulatory compliance must be conducted with consideration of the characteristics of each medical device. ISO 10993-1 categorizes medical devices based on the areas of contact with the human body and the duration of contact, providing endpoints according to the characteristics of the medical device (Table A). However, differences exist among regulatory authorities regarding the recommended testing methods and sample extraction procedures, so it is essential to thoroughly understand these differences. Our company is capable of conducting tests that comply not only with ISO 10993 but also with a wide range of regulations and standards, including FDA guidance, guidelines from the Ministry of Health, Labour and Welfare, USP, and OECD. We also provide toxicological risk assessments in addition to testing.

• Public Testing/Laboratory

In addition to the ISO 10993 series, it is possible to comply with FDA guidance, Ministry of Health, Labour and Welfare guidelines, and the United States Pharmacopeia (USP).

Medical devices that come into direct or indirect contact with human tissues are required to assess potential biological risks, such as toxicity and allergic reactions. Based on ISO 10993, it is necessary to clarify the contact form with humans, contact duration, characteristics in clinical use, manufacturing processes, physical and chemical properties, and other features, and to conduct appropriate biocompatibility tests for the target devices to evaluate biological safety. UL Solutions provides not only product safety and EMC testing and evaluation services for medical devices based on the 60601 series to comply with regulatory requirements worldwide but also non-clinical testing solutions for medical devices. In UL Solutions' non-clinical testing, we conduct tests on medical devices focusing on biocompatibility and toxicity evaluation for sterilized and non-sterilized, single-use or reprocessed products, as well as E&L (chemical characterization), cleaning, disinfection, sterilization processes, and packaging validation, ensuring safety and efficacy for patients in clinical settings, as well as compliance.

• Contract Inspection

In recent years, the implementation of maintenance DX to achieve "non-stop factories" has become an urgent necessity in manufacturing sites. Amid the trend of factory IoT and data utilization, the use of remote I/O, which can remotely aggregate and collect sensor information and control signals from equipment and sensors dispersed inside and outside the factory, is gaining importance as a foundation for predictive maintenance and condition monitoring. On the other hand, the installation environment for remote I/O is not necessarily limited to control panels or well-conditioned factory interiors. There is an increasing need to collect data in harsh environments, such as outdoor equipment and conditions involving high temperatures, low temperatures, vibrations, and strong electrical noise. Conventional remote I/O systems have struggled to operate stably under such conditions, requiring measures like installation location constraints and additional protective enclosures. Environmentally robust remote I/O with wide temperature support and noise resistance can address these challenges, enabling the expansion of the scope of factory IoT and predictive maintenance to outdoor and remote equipment. In this seminar, we will introduce the lineup of Contec's environmentally robust remote I/O, the "CONPROSYS(R) Robust I/O Series," which includes a total of 23 products.

[Speaker] Miyamoto Mariko, Senior Researcher, Public Policy Research Department, SOMPO Institute Plus Inc. [Lecture Items] 1. Overview and Latest Trends of Green Infrastructure (1) Background of Growing Attention and Market Expansion Outlook (2) Current Situation and Challenges for Promotion 2. Economic Effects of Green Infrastructure (1) Domestic Examples (Parks, Road Facilities, etc.) (2) International Examples 3. Evaluation and Certification Systems (1) Systems Related to Buildings (2) Systems Related to Sites and Urban Spaces 4. Financing Methods for Green Infrastructure (1) PPP/PFI (2) Sustainable Finance 5. Q&A / Business Card Exchange

[Lecturers] Nishimura & Asahi Law Offices, Foreign Law Joint Enterprise Attorney and Associate Iku Akamatsu Attorney and Associate Yasukazu Yamazaki (Note: "Saki" is a variant character) [Key Lecture Content] In the logistics sector and other areas, discussions are underway regarding the social implementation of drone flight routes. Drone flight routes involve various stakeholders, including drone route operators, drone operation businesses, surrounding municipalities, and ground-related parties, who collaborate and divide roles to realize these routes. Therefore, drone route operators and businesses utilizing drone routes need to enter into contracts regarding the use of drone routes with relevant parties, clarify roles, and implement appropriate risk management. This lecture will explain the legal points that must be considered when entering into contracts for the use of drone flight routes. [Lecture Items] 1. Overview of drone flight routes and recent examination status 2. Stakeholders and their roles related to drone flight routes 3. Items to consider specifying in contracts for the use of drone flight routes 4. Legal points to be aware of in contracts for the use of drone flight routes 5. Q&A / Business card exchange

[Speaker] Keiichi Koga, Senior Development Manager, Innovation Strategy Center, Japan Research Institute, Ltd. [Key Lecture Content] After the transition to the Trump administration, significant changes have emerged in the global business environment concerning the oceans, particularly regarding decarbonization and nature conservation. On the other hand, considering the accumulation of knowledge and shared understanding of the realities of the marine environment, what growth strategies should companies outline? In the financial sector, which is focusing on the expansion of the blue economy, there is a growing recognition that advancing nature-positive businesses can lead to sustainable corporate value enhancement. The sectors related to the ocean encompass not only fisheries and shipping but also a wide range of areas such as water pollution, plastic waste, tourism, and energy-related industries. This lecture will discuss the seeds for considering how businesses can transform. [Lecture Items] 1. The Blue Economy so far 2. International Trends 3. Financing Trends related to the Blue Economy 4. Directions for Business Transformation based on the Blue Economy 5. Case Studies 6. Q&A / Business Card Exchange

[Speaker] Daisuke Imaizumi, President and CEO, Infra Commons Inc. [Key Lecture Content] When companies expand their overseas operations, obtaining reliable market research and regulatory information is essential. However, reliance on traditional paid databases and specialized research firms has become a significant burden in terms of both cost and time. This seminar will introduce a new approach to overseas market research using generative AI. Specifically, we will cover a wide range of use cases, including understanding the distribution structure of niche markets, extracting key points from financial reports and research materials, collecting and summarizing information in local languages, exploring potential M&A candidates and investment trends, organizing key points of EU regulations, monitoring trends by industry and country, and understanding trends in defense and geopolitical risks. For each theme, we will specifically explain the selection of information sources, efficient research procedures utilizing generative AI, and methods for verifying sources, allowing participants to gain insights that they can immediately apply to their own work. This content is ideal for those who regularly handle overseas information in areas such as corporate planning, overseas business, new business development, and research departments. [Lecture Items] 1. Introduction 2. Utilization methods by use case 3. Summary and points to note 4. Q&A