ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry

Standard No.

ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry

Release Date

2018

Published By

International Organization for Standardization (ISO)

Latest

ISO 13485:2016

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ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry history

• 2016 ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
• 2009 ISO 13485:2003/Cor 1:2009 Medical devices - Quality management systems - Requirements for regulatory purposes; Technical Corrigendum 1
• 2003 ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• 1996 ISO 13485:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001