臺灣博碩士論文加值系統

醫療器材故障將對病人或使用者造成危害，內含軟體之醫療器材必須透過醫療器材軟體認證，有效提高醫療器材品質與使用安全性。本研究工作主要整合軟體工程技術、風險分析與管理及建構管理等技術，發展符合FDA醫療器材軟體認證指引所要求之工作內容；其中所利用之技術及應用分別為軟體開發模式採用V-model軟體開發流程於軟體開發品質管理、應用Fault Tree Analysis (FTA)進行風險分析與管理於醫療器材軟體安全性確效、透過建構管理來控管整個管理的開發流程達成整體軟體品質。本研究同時針對國內自行發展之醫療軟體---測顱分析系統，作為實例之認證與確效，並完成該醫療軟體有關軟體開發模型、需求規格、設計規格、軟體測試、驗證與確效以及風險管理之工作，最後希望所發展之各項工作文件能符合FDA醫療器材軟體上市前所需呈遞資料。

The failures of medical device might cause hazard to patients or operators. So, the software contained in a medical device should be verified and validated to insure the safety and the quality. Software engineering practices, risk analysis and management, and configuration management should be integrated in the study of software verification and validation (SV&V). Those approaches are acceptable by the FDA for the SV&V. In this work, the V-model was introduced in the software development process for the quality management of software development. The fault tree analysis (FTA) techniques were applied in the procedure of risk analysis and management for the SV&V. All of the procedures should be integrated in the so called “configuration management”. The procedures of SV&V for the developing “Cephalometric Analysis system” (CEPH) and its related works, such as software developed model, requirements specification, design specification, software test, SV&V and risk managements are also presented in the study. Finally, the documents developed in this study are hoped that to be agreeable with FDA’s conditions for the content of premarket submissions of software contained in a medical device.

摘 要 I
ABSTRACT II
誌 謝 III
目 錄 IV
表 目 錄 VI
圖 目 錄 VII
第1章 緒論 1
1.1 背景 1
1.2 研究動機 11
1.3 研究目的 12
1.4 文獻探討 13
1.5 論文架構 19
第2章 醫療器材軟體驗證與確效架構 21
2.1 軟體驗證與確效 22
2.2 風險分析與管理 23
2.3 建構管理 25
2.4 CEPH醫療器材軟體簡介 26
第3章 CEPH風險分析與管理 28
3.1 風險分析 28
3.2 危害判定 31
3.3 風險估計 32
3.4 風險控制與追蹤 33
3.5 CEPH風險分析與管理工作項目 34
第4章 CEPH軟體驗證與確效 36
4.1 軟體開發流程 36
4.2 驗證與確效 41
4.3 CEPH軟體驗證與確效工作項目 46
第5章 CEPH建構管理 48
5.1 權限管理 49
5.2 版本控制 50
5.3 軟體變更 51
5.4 CEPH建構管理工作項目 52
第6章 結果與討論 54
6.1 CEPH建構管理 54
6.2 CEPH軟體驗證與確效 59
6.3 討論 75
第7章 結論與未來展望 76
參考文獻 77

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