DIN EN ISO 13485 E:2014-04
Medical device quality management system regulatory requirements (draft)

Standard No.

DIN EN ISO 13485 E:2014-04

Release Date

1970

Published By

/

Status

Be replaced

Replace By

DIN EN ISO 13485 E:2015-05

Latest

DIN EN ISO 13485 Berichtigung 1:2017

DIN EN ISO 13485/A1:2019

DIN EN ISO 13485:2016

DIN EN ISO 13485:2021-12

DIN EN ISO 13485 E:2014-04 history

• 2021 DIN EN ISO 13485:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
• 2019 DIN EN ISO 13485/A1:2019 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
• 2017 DIN EN ISO 13485 Berichtigung 1:2017 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016
• 2016 DIN EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
• 2012 DIN EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012
• 2010 DIN EN ISO 13485:2010 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009
• 2007 DIN EN ISO 13485:2007 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007
• 2003 DIN EN ISO 13485:2003 Medical devices quality management systems requirements for regulatory purposes
• 2001 DIN EN ISO 13485:2001 Quality assurance systems for medical devices