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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 aim to minimize unnecessary details and focus on the key points that are important for manufacturers and the essential understanding they should have. We will place particular emphasis on critical aspects 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

This seminar will provide a clear explanation for manufacturers exporting medical devices and in vitro diagnostic products to the United States (U.S.) about the overall picture of U.S. medical device regulations, QSR/QMSR requirements, and FDA inspection strategies. <Content> ● Overview of U.S. medical device regulations ● Product classification ● Manufacturer registration (facility registration) and product registration ● 2024 revised version of the 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