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IEC 62304 Software Evaluation Services

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

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[Case Study] Electrical Equipment Major PC Manufacturer

[Case Study] Electrical Equipment Major PC Manufacturer

We will introduce a case that contributed to significant labor cost reduction with a proposal that delved into the test plan!

We would like to introduce a case study where a major PC manufacturer conducted a cross-evaluation of in-house and external applications, as well as the operating system and standard OS applications, to be installed on their own brand of computers. The company wanted to improve their PC/tablet evaluation methods but lacked internal expertise, and there was a desire to allocate employee hours to tasks other than evaluations. Through improvement proposals that considered not only test cases but also other business processes, they achieved approximately a 40% reduction in labor hours compared to previous methods and about a 120% increase in the number of defects detected. 【Case Overview】 ■ Issues - They had been outsourcing to another company but expressed dissatisfaction with the lack of proposals regarding upstream processes such as design and the absence of efforts to introduce new methods or improvements. ■ Results - By consistently proposing new initiatives focused on productivity, they contributed to the expansion of the areas of response within the client department. *For more details, please refer to the PDF document or feel free to contact us.

  • Company：feat
  • Price：Other
  • Embedded applications for mobile phones and PDAs

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