[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

In the operation of drawings, do you face challenges such as "taking too long to find," "uncertainty about whether it's the latest version," or "high likelihood of confirmation errors"? By utilizing CADSUPER's barcode function (optional), you can reliably connect drawings and information, allowing for a smooth advancement of DX in drawing utilization. In this seminar, we will introduce how using barcodes can change: - Drawing management and search - Confirmation and cross-checking tasks - Information collaboration with the field This content is recommended not only for existing users but also for those considering improving the efficiency of drawing operations and reducing errors.

Daitō Shikō Co., Ltd. will be exhibiting at the "International Fire and Disaster Prevention Exhibition" held at Shirakawa Park in Nagoya City, Aichi Prefecture, from Thursday, May 28, 2026. At the exhibition venue, we plan to showcase goods that are perfect for fire prevention events and recruitment activities for members. If you are looking for SP tools, promotional items, or novelties, please be sure to visit our booth.

[Speaker] Miho Ko Shimada, Partner Attorney, Mori Hamada & Matsumoto Law Firm, Foreign Law Joint Enterprise [Key Lecture Content] The movement towards the implementation of CCS, which is positioned as an essential technology for decarbonizing hard-to-abate industries, is gaining momentum in Japan. Among the "advanced CCS projects" selected for business commencement in the early 2030s, some pipeline projects have progressed to the exploratory drilling stage. For shipping transport projects, discussions are underway to create mechanisms for clustering CO2 sources and improving shipping transport efficiency. In this seminar, following the full enforcement of the CCS Business Act on May 22, we will organize the current state of the business environment related to CCS and examine the latest discussions at the Agency for Natural Resources and Energy and the Ministry of the Environment (based on information available at the time of the event) from a legal perspective as we consider the shape of CCS projects leading to Final Investment Decision (FID). [Lecture Items] 1. Current state of the business environment related to CCS 2. Overview of the CCS Business Act 3. Overview of the cost difference support system for CCS projects (pipelines) 4. Structural considerations through the CCS value chain 5. Q&A / Business card exchange

Alpha Electronics Co., Ltd. will be exhibiting at the "JISSO PROTEC 2026 (27th Assembly Process Technology Exhibition)" held at Tokyo Big Sight. This exhibition is a comprehensive showcase of electronic component assembly technology. It will be held concurrently with eight other exhibitions, including the JPCA Show, under the general title of "Total Solutions for Electronic Devices." We look forward to your visit.

The "National Roadshow," which has been held at various venues across Japan, will be transformed into an "online format." From now on, once a quarter, we will introduce content that is useful for a wide range of participants, from those considering implementation to those who want to deepen their use of Archicad/BIM, showcasing how design workflows change through the use of these tools, along with actual user cases. Participation is free, so please join us. The first online National Roadshow will focus on the theme of drawing review. Unlike the traditional 2D drawing-centered review, there is a demand for designers and application officers to adapt to a new review process based on BIM data. This online seminar will clarify the overview of the BIM drawing review system, the concepts behind the review, and the key points to be understood in practice, providing an easy-to-understand explanation of the basic knowledge necessary for application procedures. We will also address questions such as "What should I prepare first?" and "To what level should I respond with BIM?" from a practical perspective. Please join us as a first step toward using BIM for application procedures and as a platform for organizing information right after the system's launch. Since it is held online, you can participate from anywhere in the country.