SANS 13485:2004
Medical devices - Quality management systems - Requirements for regulatory purposes

Standard No.

SANS 13485:2004

Release Date

2004

Published By

ZA-SANS

Latest

SANS 13485:2004

Scope

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 customer requirements and regulatory requirements applicable to medical d

SANS 13485:2004 history

• 2004 SANS 13485:2004 Medical devices - Quality management systems - Requirements for regulatory purposes