• Journal of Internet Computing and Services
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• v.20 no.3
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• pp.69-75
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• 2019

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.

• Proceedings of the Korean Society for Quality Management Conference
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• 2004.04a
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• pp.255-260
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• 2004

IEC 60300 series, the international standards on dependability management system are newly developed and introduced rapidly worldwide. In order to meet this situation, it is necessary to apply them to the Korean industries effectively. This requires for us to prepare in advance for the introduction of the certification system of IEC 60300. It includes the establishment of the infrastructure such as documentation of Korean Standards, introduction of test equipments and test manuals, recognition of the certification body and training of specialists etc. This paper addresses the first step for the Introduction of IEC 60300. It includes the necessity of introduction of the system, general requirements and procedures for the certification of the industries, sampling methods design and establishment of the dependability assurance system of the materials.

• Proceedings of the Safety Management and Science Conference
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• 2004.05a
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• pp.161-167
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• 2004

IEC 60300 series, the international standards on reliability management system are newly developed and introduced rapidly worldwide. In order to meet this fast-changing situation, it is necessary to apply them to the Korean industries effectively. It includes the establishment of the infrastructure such as documentation of Korean Standards, introduction of test equipments and test manuals, accreditation of the certification body and training of the specialists etc. IEC 60300 is upgraded management system of the ISO 9000 and ISO 14000. In this regard, the Korean companies which was certified with the ISO 9000 or 14000 should endeavor to find new strategies and methods to be certified with ISO 60300. This paper introduces a quantitative method of estimating the level of the reliability management system by applying the MIR(Maturity Index on Reliability) technique. This enables the estimation of the operation level of the system and can upgrade the maturity level of it.

• The Monthly Technology and Standards
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• s.79
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• pp.102-105
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• 2008

• The Monthly Technology and Standards
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• s.115
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• pp.43-43
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• 2011

• The Monthly Technology and Standards
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• s.114
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• pp.48-48
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• 2011

• The Monthly Technology and Standards
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• s.71
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• pp.114-127
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• 2007

• The Monthly Technology and Standards
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• s.78
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• pp.131-142
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• 2008

• The Monthly Technology and Standards
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• s.64
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• pp.124-137
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• 2007

• The Monthly Technology and Standards
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• s.68
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• pp.88-93
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• 2007