[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

Zaltrius Japan will be exhibiting at the 98th Annual Meeting of the Japanese Society for Tissue Culture. ◼ Date: August 27 (Thursday) - 28 (Friday), 2026 ◼ Location: 2-8-35 Tai-machi, Nagaoka City, Niigata Prefecture, Hotel New Otani Nagaoka, Venue for the 98th Annual Meeting of the Japanese Society for Tissue Culture ◼ Booth: No. 11 ◼ Exhibited Products: Polyplus High-Efficiency Transfection Reagents NexaGel 3D Cell Culture Matrix Research Growth Factors and Cytokines Basic Cell Culture Media and Reagents Picus 2 Electronic Pipette We have a selection of products recommended for those considering improving research reproducibility and establishing 3D culture environments. Please come and see the actual products and applications at the venue. We look forward to your visit!

We are pleased to announce a co-hosted seminar with Live Consulting Co., Ltd. "Practical Seminar on Microsoft Copilot for Executives and Managers in the Manufacturing Industry" "The new AI tools are no longer needed." This seminar will allow you to experience Microsoft Copilot, which can be used directly within your usual Word, Excel, and Teams, through a demonstration of the actual operation screen. The answers are already within your existing Microsoft 365. You can use AI directly in Word, Excel, and Teams without the need for additional tool selection or new investments, all within the security framework of M365. We will explain the basics to practical applications of Copilot in 90 minutes, specifically for executives and managers in the manufacturing industry. We sincerely look forward to your participation. [Recommended for the following individuals] - Executives and managers in the manufacturing industry who have not yet mastered generative AI/Copilot - Those considering AI implementation but are stalled due to tool selection, security, or promotion systems - Individuals who prefer to see the "actual screen" rather than just "reading" about it - Those who are unable to use ChatGPT in their company due to security concerns.

We will hold a webinar focused on analytical challenges in the research, development, and quality control of biopharmaceuticals, particularly antibody-drug conjugates (ADCs). We are pleased to invite Professor Yuji Ito from Kagoshima University, who will give a lecture on the latest analytical strategies and practical insights in biopharmaceutical research, including ADCs. Target Audience: - Researchers, developers, and CMC personnel from pharmaceutical companies, CDMOs, and CROs - Those considering advanced analytical methods for ADCs and antibody drugs - Individuals facing challenges in improving separation performance, reproducibility, or analytical efficiency - Those considering the implementation of MAM and workflow development Lecture 1 [Special Lecture]: Next-Generation Drug Discovery Using DDS with Tissue-Translocating Antibodies - AccumBody Platform and Antibody Conjugate Technology - Professor Yuji Ito, Graduate School of Science and Engineering, Kagoshima University Lecture 2: Latest LC Column Technology to Solve Challenges in ADC and Antibody Analysis Lecture 3: MAM Practice - An Integrated Workflow from Research and Development to Quality Evaluation * This webinar is a restructured version of the content from the on-site seminar held in July 2026.

Fujikogyo Co., Ltd. will exhibit at the "5th Smart Factory EXPO Autumn" held at Makuhari Messe from September 9 (Wednesday) to September 11 (Friday), 2026. On the day, we will showcase the latest FA and robotics products that achieve automation, efficiency, and labor-saving in the field. [Main Exhibited Products] ◇ Collaborative Robot Palletizing System (Elite Robot Co.) A compact design that is mobile and integrated. It enables seamless loading and easy operation via a tablet. ◇ Autonomous Mobile Robot for Pallet Transport (FEXA Co.) A small and agile AMR. It supports fully automated transportation through shutter and elevator coordination and the use of load sensors. ◇ Automatic Sealing Machine for Packing Tape (EXTEND Co.) Compliant with decarbonization and environmental considerations. It can be used with only power, without the need for air, allowing for use without constraints of location or utilities. We will propose solutions that help solve your challenges. Please visit our booth (Hall 2 / A13-36). *Advance registration (free) is required for attendance.

The organization will hold a seminar titled "EMC Performance of In-Vehicle Devices as Considered by Automobile Manufacturers" on September 16, 2026 (Wednesday), featuring lecturers from Toyota Motor Corporation, Hino Motors, Ltd., and Daihatsu Motor Co., Ltd. In addition to presentations from the three companies, a leading expert on in-vehicle device EMC from our organization will introduce the latest topics. Furthermore, after the seminar, a technical exchange meeting will be held, allowing participants, lecturers, and our organization's technical staff to exchange information. In recent years, the acceleration of autonomous driving, connectivity, and electrification technologies has been aimed at achieving carbon neutrality and evolving mobility. Within this context, it is anticipated that the demands for EMC in electric vehicles (xEV) and fuel cell vehicles (FCV), particularly regarding the electrification of powertrains and EV components, will be stronger than ever. In this seminar, we will invite EMC experts from automobile manufacturers to explain the latest trends in standards regarding the "EMC performance required for in-vehicle devices" to suppliers. We encourage you to take advantage of this opportunity.