UNE-EN ISO 13485:2018/A11:2022
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Standard No.

UNE-EN ISO 13485:2018/A11:2022

Release Date

2022

Published By

ES-UNE

Latest

UNE-EN ISO 13485:2018/A11:2022

UNE-EN ISO 13485:2018/A11:2022 history

• 2022 UNE-EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• 2018 UNE-EN ISO 13485:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
• 2013 UNE-EN ISO 13485:2013 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)