• Journal of Internet Computing and Services
    ISSN 2287 - 1136(Online) / ISSN 1598 - 0170 (Print)
    http://jics.or.kr/

Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software


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

Abstract

The safety and performance of medical device software is managed through life-cycle processes, which represent the entire process of research and development (R&D). The life-cycle process of medical device software is represented by an international standard called IEC 62304, ISO/IEC 12207. In order to license the product, the manufacturer must have document artifacts that comply with the IEC 62304 standard. However, these standards only describe the content of the activity and do not provide a method or procedure for documentation. Therefore, this paper suggests R&D documentation guidelines that assist medical device software developers to have R&D documents conforming to the standards. For this purpose, this study identifies the requirements related to documentation among the requirements existing in the standard and extracts them in the form of guidelines showing only the core information of the requirements. In addition, through the Web framework implemented based on this research, the developer can evaluate whether the technical documents are written in accordance with the R&D document guidelines. Medical device software manufacturers can efficiently produce high-quality research and development documents through R&D documentation guidelines, and they can have standards-compliantresearch and development documentation required for licensing procedures.


Statistics
Show / Hide Statistics

Statistics (Cumulative Counts from November 1st, 2017)
Multiple requests among the same browser session are counted as one view.
If you mouse over a chart, the values of data points will be shown.


Cite this article
[APA Style]
DongYeop Kim, Byungjeong Lee, & Jung-Won Lee (2019). Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software. Journal of Internet Computing and Services, 20(3), 69-75. DOI: 10.7472/jksii.2019.20.3.69.

[IEEE Style]
D. Kim, B. Lee and J. Lee, "Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software," Journal of Internet Computing and Services, vol. 20, no. 3, pp. 69-75, 2019. DOI: 10.7472/jksii.2019.20.3.69.

[ACM Style]
DongYeop Kim, Byungjeong Lee, and Jung-Won Lee. 2019. Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software. Journal of Internet Computing and Services, 20, 3, (2019), 69-75. DOI: 10.7472/jksii.2019.20.3.69.