
MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS
出版:Association for the Advancement of Medical Instrumentation

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基本信息
標準編號: AAMI ISO TIR 80002-2 : 2017
標準類別:Standard
出版單位:Association for the Advancement of Medical Instrumentation
標準頁數:0
標準簡介
Pertains to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.