As an IAS ISO/IEC 17025 accredited testing laboratory for IEC 62304, we provide evaluation services for embedded software.
IEC 62304 (JIS T 2304: Medical Device Software Software Life Cycle Processes) specifies the requirements for the life cycle processes of medical device software and serves as a requirement for obtaining regulatory approval in regions such as Europe, the United States, and Japan. Our company is accredited by the ILAC-accredited organization IAS in the United States for ISO/IEC 17025 certification of IEC 62304 (Medical device software – Software life cycle processes), and you can utilize the 62304 evaluation report with our support.
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Our company provides evaluation services for software embedded in medical electrical equipment, conducting these evaluations alongside electrical safety testing. ■ IEC 62304 Standard Consultation ■ Evaluation services based on IEC 62304 ed.1.1 (JIS T 2304: 2017) In addition to electrical safety testing, we can offer proposals that include reliability testing such as environmental testing, EMC (electromagnetic compatibility) testing, and biocompatibility testing. Please feel free to consult with us according to your company's needs.
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**Overview of UL** UL addresses challenges in safety, security, and sustainability through the application of science, contributing to the creation of a better world. By enabling the safe introduction of advanced products and technologies, UL enhances trust. The staff at UL share a passion for making the world a safer place. From third-party research to standards development, testing, certification, and the provision of analysis/digital solutions, UL aims to build a healthier global society through its operations. The trust in UL supports smart decisions made by businesses, manufacturers, government authorities, regulatory agencies, and individuals. For more details, please refer to the website (UL.com). **Overview of UL Japan, Inc.** UL Japan, Inc. was established in 2003 as the Japanese subsidiary of UL, a global third-party safety science organization. Currently, leveraging UL's global network, it provides conformity assessment services for certification marks required for products in the North American UL mark, as well as safety and EMC certification PSE and S marks based on Japan's Electrical Appliance and Material Safety Law, and certification marks needed for the European and Chinese markets.