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IEC 62304 Software Evaluation Services

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.

  • Contract Inspection
  • IEC Software Evaluation Service

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