ISO-13485 › Medical devices - Quality management systems - Requirements for regulatory purposes

ISO-13485 - 3RD EDITION - CURRENT
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Medical devices - Quality management systems - Requirements for regulatory purposes
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03.100.70 (Management systems Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject Including environmental management systems (EMS), road traffic management systems, energy management systems, health care management systems, etc.)

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