DS/EN ISO 13485/AC:2012
Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1

Standard No.

DS/EN ISO 13485/AC:2012

Release Date

2012

Published By

Danish Standards Foundation

Status

Be replaced 2021-09

Replace By

DS/EN ISO 13485:2021

Latest

DS/EN ISO 13485:2021

Scope

ISO 13485:2003 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 applicabl

DS/EN ISO 13485/AC:2012 history

• 2021 DS/EN ISO 13485:2021 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
• 2012 DS/EN ISO 13485/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
• 2012 DS/EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
• 0000 DS/EN ISO 13485/AC:2009
• 0000 DS/EN ISO 13485/AC:2007
• 0000 DS/EN ISO 13485:2003