DSF/FPREN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/FDIS 13485)
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 58 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
This International Standard specifies requirements for an organization that needs to demonstrate that its quality management system has the ability to manage the life-cycle of medical devices and associated activities consistently to meet customer and appropriate regulatory requirements. It may also be used by suppliers or external parties that provide goods and quality system related services to medical devise organizations.
Document History
September 13, 2021
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
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...
April 3, 2018
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...
January 6, 2017
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
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...
March 1, 2016
Medical devices – Quality management systems – Requirements for regulatory purposes
A description is not available for this item.
March 1, 2016
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...
August 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
ISO 13485:2003 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...
February 28, 2012
Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 13485:2003 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 30, 2009
Medical devices - Quality management systems - Requirements for regulatory purposes
This standard 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...
July 23, 2007
Medical devices - Quality management systems - System requirements for regulatory purposes
This standard 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 29, 2003
Medical devices - Quality management systems - System requirements for regulatory purposes
This standard 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...
February 9, 2001
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
The standard specifies, in conjunction with ISO 9001, the quality system requirements for the design/development, production, and when relevant, installation and servicing of medical devices. The...
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
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...
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015)
This International Standard specifies requirements for an organization that needs to demonstrate that its quality management system has the ability to manage the life-cycle of medical devices and...
DSF/FPREN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/FDIS 13485)
This International Standard specifies requirements for an organization that needs to demonstrate that its quality management system has the ability to manage the life-cycle of medical devices and...