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Search: "[ keyword: Medical Device Software ]" (2)

1. A Safety Process Guideline of Medical Device System Based on STPA

Bo-yoon Choi, Byong-gul Lee, Vol. 22, No. 6, pp. 59-69, Dec. 2021
10.7472/jksii.2021.22.6.59
Keywords: Medical Device Software, Safety process, STPA
2. Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software

DongYeop Kim, Byungjeong Lee, Jung-Won Lee, Vol. 20, No. 3, pp. 69-75, Jun. 2019
10.7472/jksii.2019.20.3.69
Keywords: Medical Device Software, Standard, IEC 62304, ISO/IEC 12207, Documentation Guideline