DS/EN ISO 13485:2021
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)

Standard No.

DS/EN ISO 13485:2021

Release Date

2021

Published By

Danish Standards Foundation

Latest

DS/EN ISO 13485:2021

DS/EN ISO 13485:2021 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