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日期:2024-09-06
關鍵零組件. 技術分析. 設計開發非臨床試驗. 製程建立. 查驗登記. 臨床評估. 醫療器材優良製造規範(GMP). 醫療器材業品質管理系統驗證(ISO 13485). 許可證核發....
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日期:2024-09-11
A free PowerPoint PPT presentation (displayed as a Flash slide show) on ... Quality System Regulations ISO 13485 Regulatory Inspections - PowerPoint PPT ......
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日期:2024-09-11
The ISO 13485 was designed for organizations that provide medical devices or related services. ... Consider this PowerPoint: ISO 13485 executive overview....
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日期:2024-09-08
Process-oriented structure. ISO 13485:2003 promotes a process approach when developing ... specified in 7.1 of ISO 13485 dealing with product realization. In....
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日期:2024-09-12
US/FDA: Quality Management System per 21 CFR820, Quality System Regulation; Europe, Canada, and Other International: QMS per EN/ISO 13485:2003, ......
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日期:2024-09-07
ISO 13485 is a version of the standard developed for the Medical Device Industry. It contains most of the requirements of ISO 9001 plus several additional ......