DIN EN ISO 13485/A1:2019-11
Superseded Draft amendment
Historical

DIN EN ISO 13485/A1:2019-11

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
Most recent standard
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Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 11/01/2019
Page Count 8
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Previous versions

DIN EN ISO 13485:2021-12

DIN EN ISO 13485:2021-12

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
01/12/2021
Active
Most Recent
DIN EN ISO 13485/A1:2019-11

DIN EN ISO 13485/A1:2019-11

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
01/11/2019
Superseded
Historical
DIN EN ISO 13485 Berichtigung 1:2017-07

DIN EN ISO 13485 Berichtigung 1:2017-07

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
01/07/2017
Superseded
Historical
DIN EN ISO 13485:2016-08

DIN EN ISO 13485:2016-08

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016.
01/08/2016
Superseded
Historical
DIN EN ISO 13485:2015-05

DIN EN ISO 13485:2015-05

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015
01/05/2015
Superseded
Historical
DIN EN ISO 13485:2014-04

DIN EN ISO 13485:2014-04

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2014); German version prEN ISO 13485:2014
01/04/2014
Superseded
Historical
DIN EN ISO 13485:2012-11

DIN EN ISO 13485:2012-11

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012.
01/11/2012
Superseded
Historical
DIN EN ISO 13485:2010-01

DIN EN ISO 13485:2010-01

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009
01/01/2010
Superseded
Historical
DIN EN ISO 13485:2001-02

DIN EN ISO 13485:2001-02

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (Identical to ISO 13485:1996); German version EN ISO 13485:2000.
01/02/2001
Superseded
Historical
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