US ISO 13485:2003

Medical devices - Quality management systems -Requirements for regulatory purposes


Abstract

This Uganda Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. This standard was PUBLISHED on 2011-12-20.

This Standard was withdrawn and replaced by :

  US ISO 13485:2016

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US ISO 9001:2015

Quality management systems - Requirements

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