ISO-13485 › Historical Revision Information
Medical devices - Quality management systems - Requirements for regulatory purposes
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Medical devices - Quality management systems - Requirements for regulatory purposes
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03.120.10 (Quality management and quality assurance)
11.040.01 (Medical equipment in general)
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Document Number
ISO 13485:2016
Revision Level
3RD EDITION
Status
Current
Publication Date
March 1, 2016
Committee Number
ISO/TC 210