數位治療是一種新興的治療方式，因此醫療器材軟體（SaMD）的使用已變得普遍。然而，軟體缺陷的問題仍未得到解決。為了確保軟體的有效性，各種監管機構已經制定了規定。為了解決這個問題，我們開發了一種新的軟體開發流程，結合了V模型、醫療器材標準，以及美國食品藥品監督管理局對醫療器材內含軟體的上市申請內容指南（2021）。我們在ADHD虛擬現實教室的數位治療中的驗證了這個新流程可行性。研究結果顯示，開發流程確保品質滿足FDA的要求。此流程也有效地管理了從需求分析到最終軟體釋出的各個軟體開發階段。這個流程為未來醫療器材軟體開發的標準提供了基礎。;Digital therapeutics is an emerging treatment method. Thus, medical as device software (SaMD) has become widely used. However, the issue of software defects is to be solved yet. To ensure the effectiveness of the software, various regulatory agencies have established regulations. To solve this issue, we developed a new software development process combining the V-model, medical device standards standard, and FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (2021). We verified the feasibility of the new process for digital therapy in the ADHD VR Classroom. The research results showed that the developed process ensured its quality to meet the FDA′s requirements. The process effectively manages the various stages of software development from requirementanalysis to the final software release. This process provides the basis as a standard for future medical device software development.
