[Introduction to Medical Device Safety Standards Webinar 2026] Session 1: Medical Device Regulations and Safety Standards

UL Japan

We will hold the "Introduction to Medical Device Safety Standards Webinar Series," which has received great acclaim every year, in 2026 with updated content. While incorporating the latest information, we will clearly explain the overview of standards related to medical devices, as well as key points for safety testing and evaluation. Please also utilize this as internal training for those involved in development, regulatory affairs, and quality control at medical device manufacturers. In this webinar, participants will understand the legal content through domestic medical device regulations and will be introduced to related safety testing and evaluation standards. Additionally, this webinar is positioned as an introduction to the series "Introduction to Medical Device Safety Standards Webinar 2026," and the details of each testing and evaluation standard will be structured to be learned individually within each theme of the series.

Date and time Tuesday, Mar 31, 2026
02:00 PM ～ 02:50 PM
Capital
Entry fee Free

Related product information

Testing and evaluation services related to medical devices
Providing solutions for the global market.

■ Product safety standards evaluation, testing, and certification services ■ EMC testing services ■ Software evaluation services ■ Cybersecurity testing services for medical devices ■ Biological evaluation and biocompatibility testing services ■ ISO 13485 quality management system audit and registration services
Medical device product safety standards evaluation, testing, and certification services.
Compliance with IEC 60601, IEC 61010, and various individual standards.

■ Technical consultation ■ Structural evaluation services ■ Contracted business testing ■ Testing laboratory accreditation ■ EMC testing and wireless standard testing ■ Radio wave regulations in various countries
Medical Device EMC Testing Services
Manufacturers need to demonstrate compliance with regulations regarding safety and performance requirements to ensure product safety and market entry.

The conformity of medical devices to EMC has recently become a significant issue, as it can pose a threat to life. If a product does not conform to the intended environment, it becomes difficult to ensure safety compliance and to achieve its intended effects. EMC testing evaluates the potential for interference between nearby products and the risk of injury or damage to people and the surrounding environment. Additionally, these tests assess the compatibility of devices under the intended electromagnetic environment. In many countries, EMC, radio, and radio frequency (RF) exposure and safety requirements are established. For medical products, several standards are set regarding testing, risk management, basic safety, and essential performance. For example, medical devices sold in the United States must comply with IEC 60601-1-2, 4th edition. The IEC 60601-1-2, 4th edition defines the fundamental safety and essential performance of medical devices concerning radiation and immunity to electromagnetic interference. As of the latest information, the U.S. Food and Drug Administration (FDA) has recognized the 4.1 edition as a Recognized Consensus Standard in December 2023.
[On-Demand Webinar] Cybersecurity for Medical Devices
I want to know about this! Cybersecurity standards for medical devices IEC 81001-5-1.

- Requirements of IEC 81001-5-1 - What is an activity? - Security functions and security context - Threat modeling and trust boundaries - Secure coding guidelines and so on.
Brazilian medical devices and INMETRO certification
Response to Brazil INMETRO

UL Solutions provides support necessary for obtaining certification as an INMETRO product certification body (OCP) in Brazil. Furthermore, for safety testing of target products required for certification (electrical safety, EMC, usability, software) and quality system audits for manufacturers, we conduct safety tests based on ISO 17025, with domestic inspectors who have extensive experience in factory inspections.