NEN-EN-ISO 13485/C11
Medical devices - Quality management systems - Requirements for regulatory purposes
active
| Organization: | NEN |
| Publication Date: | 1 January 2017 |
| Status: | active |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
| ICS Code (Management systems): | 03.100.70 |
scope:
This corrigendum modifies NEN-EN-ISO 13485:2016.
Document History
September 1, 2021
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
NEN-EN-ISO 13485/C11
January 1, 2017
Medical devices - Quality management systems - Requirements for regulatory purposes
This corrigendum modifies NEN-EN-ISO 13485:2016.
March 1, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
NEN-EN-ISO 13485 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...
September 1, 2009
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
July 1, 2007
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
April 1, 2006
Medical devices - Quality management systems - Requirements for regulatory purposes
This correction notice contains corrections on the Dutch translation of NEN-EN-ISO 13485:2003.
August 1, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...