Evaluation of medical software - メーカー・企業と業務用製品 | イプロスものづくり

[Case Study] Medical Devices Medical Software Development Company

Introducing examples of software evaluation based on CSV (Computerized System Validation)!

We would like to introduce a case that broadly addresses tasks related to the evaluation of medical AI software. At that time, the customer was utilizing another company but recognized challenges such as high costs and the need for detailed inputs to achieve the desired quality. By engaging our services, we improved document quality through enhancements to the test specification format, review record sheets, review checklists, and the creation of automated check tools, while achieving testing at a level equal to or above that of other companies at about half the cost. [Case Overview] ■Challenges - High costs and the need for detailed inputs to achieve the desired quality. ■Results - Achieved a highly comprehensive test design that ensured traceability between requirement definition documents, risk management sheets, and test items. *For more details, please refer to the PDF document or feel free to contact us.