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DIN EN ISO 13485 BERICHTIGUNG 1

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

active, Most Current
Organization: DIN
Publication Date: 1 July 2017
Status: active
Page Count: 23
ICS Code (Medical equipment in general): 11.040.01
ICS Code (Management systems): 03.100.70

Document History

November 1, 2019
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
A description is not available for this item.
DIN EN ISO 13485 BERICHTIGUNG 1
July 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
A description is not available for this item.
August 1, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation gefordert ist, ihre Fähigkeit zur Bereitstellung von Medizinprodukten und zugehörigen...
May 1, 2015
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015
A description is not available for this item.
April 1, 2014
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2014); German version prEN ISO 13485:2014
Allgemeines Diese Internationale Norm legt Anforderungen an eine Organisation fest, die darlegen muss, dass ihr Qualitätsmanagementsystem in der Lage ist, den Lebenszyklus von Medizinprodukten und...
November 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012
Allgemeines Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation ihre Fähigkeit zur Bereitstellung von Medizinprodukten und zugehörigen...
January 1, 2010
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009
A description is not available for this item.
October 1, 2007
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007
A description is not available for this item.
November 1, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003
A description is not available for this item.
February 1, 2001
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
A description is not available for this item.
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