:

I-Ching Tsai1, Ching-Da Wang1, Peng-Ting Chen1,2

  • 1Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan.

概括

医疗器械开发需要一个结构化的方法,首先关注组织因素,然后是技术能力和环境,最后是用户的行为. 这确保了产品的安全性和有效性.

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