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BSI - BS EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

active, Most Current
Organization: BSI
Publication Date: 31 March 2016
Status: active
Page Count: 68
ICS Code (Quality management and quality assurance): 03.120.10
ICS Code (Medical equipment in general): 11.040.01

Document History

November 7, 2019
Draft BS EN ISO 13485 Amendment 1 - Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
BS EN ISO 13485
March 31, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
March 31, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
March 31, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
February 29, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
March 31, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
March 31, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
July 24, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
July 24, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
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...
July 24, 2003
Medical devices Quality management systems Requirements for regulatory purposes
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...
March 15, 2001
Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001
To be read in conjunction with BS EN ISO 9001:1994

References

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