[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

We would like to extend our heartfelt congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will showcase a variety of products, including new ones. We sincerely invite you to visit us during this busy time. 【 Exhibition Name 】 Automotive Technology Exhibition 2025 YOKOHAMA https://aee.expo-info.jsae.or.jp/ja/yokohama/ (An "online exhibition" will also be held during and around the event period) 【 Dates 】 May 21 (Wednesday) - 23 (Friday), 2024 10:00 AM - 6:00 PM *On the final day, 9:00 AM - 4:00 PM (Online exhibition: May 14 (Wednesday) - June 4 (Wednesday)) 【 Venue 】 Pacifico Yokohama (1-1-1 Minatomirai, Nishi-ku, Yokohama, Kanagawa Prefecture) Our booth number: "Concourse 505"

We would like to extend our heartfelt congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will showcase a variety of products, including new ones. We sincerely apologize for the inconvenience during your busy schedule, but we would like to invite you to attend this event. 【 Exhibition Name 】 27th INTERPHEX Week Tokyo https://www.interphex.jp/tokyo/ja-jp.html 【 Dates 】 July 9 (Wednesday) - 11 (Friday), 2025 10:00 AM - 5:00 PM 【 Venue 】 Tokyo Big Sight (3-11-1 Ariake, Koto-ku, Tokyo 135-0063)

Nitto Kohki will exhibit at the "H₂ & FC EXPO Spring International Hydrogen and Fuel Cell Exhibition" held at Tokyo Big Sight, West Exhibition Hall 2, from February 28 (Wednesday) to March 1 (Friday), 2024. [Booth Number: W14-63] The quick fluid coupling "Coupler" is a product that allows for the rapid connection and disconnection of piping for various fluids such as air, water, oil, and chemical solutions. At this exhibition, we will primarily showcase the high-pressure hydrogen filling quick fluid coupling "HHV Coupler."

Nitto Kohki will exhibit at the "22nd H₂ & FC EXPO Autumn International Hydrogen and Fuel Cell Exhibition" held at Makuhari Messe Hall 8 from October 2 (Wednesday) to October 4 (Friday). [Booth Number: E22-14] The rapid fluid connector "Coupler" is a product that allows for quick connection and disconnection of piping for various fluids such as air, water, oil, and chemical solutions. At this exhibition, we will primarily showcase the high-pressure hydrogen filling rapid fluid connector "HHV Coupler."

Nitto Kohki will hold the "2025 Attack Fair in Meiko" for two days from July 23 (Wednesday) to July 24 (Thursday), 2025, at the "Kowa Seminar Plaza 2F Training Room NO.12 (inside Kowa Sports Land)." The Attack Fair is an exhibition where you can actually "see, touch, and operate" Nitto Kohki's products. Additionally, there will be wonderful souvenirs for attendees and many fun activities planned. We look forward to welcoming everyone!