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ISO 13485 : Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
ISO 13485 : Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
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医療機器－品質マネジメントシステム－規制のための要求事項。ISO 9001を基本としつつ、医療機器特有の要求事項が規定された、医療機器の製造管理、品質管理に係る基準。
医療機器－品質マネジメントシステム－規制のための要求事項。ISO 9001を基本としつつ、医療機器特有の要求事項が規定された、医療機器の製造管理、品質管理に係る基準。
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