SNV - SN EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes
active
| Organization: | SNV |
| Publication Date: | 1 March 2016 |
| Status: | active |
| Page Count: | 70 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
Document History
November 1, 2021
Medical devices - Quality management systems - Requirements for regulatory purposes; Amendment A11
A description is not available for this item.
April 1, 2020
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); Corrigendum AC
A description is not available for this item.
SN EN ISO 13485
March 1, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
September 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
General
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...
January 1, 2010
Medical devices - Quality management systems - Requirements for regulatory purposes; Corrigendum AC
A description is not available for this item.
September 1, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13845:2003)
A description is not available for this item.