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.
basic information
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.
Price information
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Applications/Examples of results
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