NEN-EN-ISO 13485/A11
Medical devices - Quality management systems - Requirements for regulatory purposes
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 September 2021 |
| Status: | active |
| Page Count: | 30 |
| ICS Code (Medical equipment in general): | 11.040.01 |
| ICS Code (Management systems): | 03.100.70 |
Document History
NEN-EN-ISO 13485/A11
September 1, 2021
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
May 1, 2018
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
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...
August 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
February 1, 2012
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...
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.
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...
December 1, 2000
Quality systems - Medical devices - Particular requirements for the application of ISO 9001
Specifies, in conjunction with the application of ISO 9001, the quality system requirements for the design/development and, when relevant, installation and servicing medical devices.