DIN EN ISO 13485:2021-12
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021

Standard No.

DIN EN ISO 13485:2021-12

Release Date

2021

Published By

German Institute for Standardization

Latest

DIN EN ISO 13485:2021-12

DIN EN ISO 13485:2021-12 history

• 2021 DIN EN ISO 13485:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
• 2019 DIN EN ISO 13485/A1:2019 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
• 2017 DIN EN ISO 13485 Berichtigung 1:2017 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016