EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
This International Standard specifies requirements for a quality management system where an organizationneeds to demonstrate its ability to provide medical devices and related services that consistently meetcustomer requirements and regulatory requirements applicable to medical devices and related services.
EN ISO 13485:2012 history
2021EN ISO 13485:2016/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
2018EN ISO 13485:2016/AC:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
2016EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
2012EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
2003EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Incorporating corrigendum June 2007 [Superseded: CEN EN 46003, CEN EN ISO 13488]
2000EN ISO 13485:2000 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001 Revision of EN 46001:1996; Identical to ISO 13485:1996