ISO/TR 80002-2:2017 筆記

名詞:

Confidence-building activities: 建立信任的活動

Critical Thinking : 批判性思考,分析後可導出軟體確效方式.須避免使用one-size-fits-all來確效所有軟體.

Throughout the life cycle of software for medical device quality system , appropriate controls need to place to ensure that the software performs as intended. 醫療設備品質系統的軟體生命週期期間, 需要適當的管制確保軟體施行的需要.