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醫療器械生產質量管理體系 ISO 13485:2016

1. 目的和范圍1.1ISO 13485:2016規定了醫療器械組織的質量管理體系要求，涵蓋設計、開發、生產、安裝和服務的各個階段。1.2適用于任何參與醫療器械生命周期的組織，無論其規模或類型。2. 風險管理強調在整個產品生命周期中實施風險管理，確保醫療器械的安全性和性能。3. 法規要求,要求組織識別并遵守適用于其醫療器械的所有

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