醫療器材法規小學堂- 【＃一分鐘搞懂系列】GHTF STED 上市 ...
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以前歐盟醫療器材指令(MDD 93/42/EEC amended by Directive 2007/47/EC) 對於技術文件並沒有架構與內容上明確的要求。
如今歐盟醫療器材法規(MDR ...
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As you are probably aware, EU Directive 2007/47/EC modifies the Medical Devices and Active Implan...
