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논문검색

Quality Assessment Framework for Medical Device specific SW R&D Project

초록

영어

R&D software development project has different goals and different organization structure. The importance of medical device software is increasing as the quality of medical device. But the quality capability of medical device specific SW R&D project members is not mature so the CMM-I and SPICE framework is not appropriate. In this paper, we suggest quality assessment framework for medical device software process in R&D project. We identify the critical features of medical device software1) safety 2) standardization 3) continuing change. With these feature, we suggested quality assessment scheme and evaluation procedure.

목차

Abstract
 1. Introduction
 2. Research Method and Related Works
  2.1. Research Scope and Definition and Characteristics of R&D SW scope of medical Devices
  2.2. Analysis of Quality Certification Standard
 3. SW R&D Quality Assessment Model and Evaluation Procedure
  3.1. Features of Medical Device R&D SW
  3.2. Quality Assessment Model
  3.3. SW Quality Evaluation Procedure
 4. Conclusion
 References

저자정보

  • Jeong Ah Kim Kwandong University, Korea
  • JaeHo Kim ValueOne Consulting Corp.

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