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EVS-EN ISO 13485:2004

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

General information

Withdrawn from 03.05.2012
Base Documents
ISO 13485:2003; EN ISO 13485:2003+AC:2009
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.05.2012
Main + corrigendum
08.10.2009
Corrigendum
EVS-EN ISO 13485:2004/AC:2009
06.08.2007
Corrigendum
EVS-EN ISO 13485:2004/AC:2007
Main + corrigendum
EVS-EN ISO 13485:2004
Main
EVS-EN 46003:2000
Main
EVS-EN ISO 13485:2002
Main
EVS-EN ISO 13488:2002
This International 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.

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