テュフズードジャパン List of News Articles

In recent years, due to concerns about radiation and expectations for accurate image analysis, the use of MRI imaging has been increasing in various countries. On the other hand, incidents occurring in hospitals during MRI use are still not widely known, making it difficult to say that sufficient consideration for safety during use is being given. Particularly in Japan, unlike in the United States and Europe where verification of MRI safety through testing is mandatory, while documentation is required, it is also permissible to state "evaluation not conducted," meaning that safety assessment is not mandatory. There are accidents that can be prevented by not bringing medical devices into the MRI, but for medical devices that cannot be removed, it is necessary to clearly understand the associated risks. This webinar aims to introduce the regulatory frameworks of major markets and what is actually happening in medical settings, helping participants understand the considerations for MRI safety that are required on-site. ■ Date and Time November 27, 2024 (Wednesday) 13:00 - 16:00 ■ Recommended for - Regulatory affairs personnel, design developers, and sales representatives of medical device manufacturers.

In this seminar, we will explain the overview and impact of the Cyber Security Act, NIS2 Directive, and Cyber Resilience Act, which are expected to affect domestic companies among various regulations. Given the complex interrelation of these laws, we will minimize the details as much as possible and focus on the key points that are important for manufacturers and the essential aspects that need to be understood. We will place particular emphasis on important parts for suppliers in the supply chain (such as scope of application and mandatory requirements) as we proceed with the explanation. <Seminar Topics> - Trends in cybersecurity standards and regulations in the industry - Key points of the EU Cyber Security Act - Key points of the EU NIS2 Directive - Key points of the EU Cyber Resilience Act - Relationship between the Cyber Resilience Act and IEC 62443 - Schedule of security regulations from the perspective of manufacturers

TÜV SÜD has issued ISO 9001 certification for Hino Motors, Ltd. (Headquarters: Hino City, Tokyo; President: Satoshi Ogiso). ISO 9001 is the most widely adopted quality management system standard in the world, and to obtain it, a management system must be established based on the requirements, and it must pass the certification body’s audit. TÜV SÜD, as a third-party certification body, provides certification and audit services to meet the requirements of ISO 9001. Recently, TÜV SÜD issued ISO 9001 certification for Hino Motors, Ltd. for the design and development process of engines for trucks and buses intended for domestic and overseas markets, as well as for the application process for engine certification to the authorities. This certification demonstrates that the company's quality management in the relevant processes meets international standards. In the future, TÜV SÜD will continue to contribute to the foundation building and improvement of domestic businesses through various audit and system certification services.

This seminar will provide a clear explanation of the overall picture of U.S. medical device regulations, QSR/QMSR requirements, and FDA inspection strategies for manufacturers exporting medical devices and in vitro diagnostic products to the United States. <Content> ● Overview of U.S. medical device regulations ● Product classification ● Manufacturer registration (facility registration) and product registration ● 2024 revised Quality Management System Regulation (QMSR) ● Quality System Regulation (QSR) ● Quality System Inspection Technique (QSIT) ● Medical Device Reporting System (MDR) ● FDA inspections ● Responses to FDA inspection findings ● 21 CFR 820, English-Japanese comparison of QSR/QMSR requirements