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
- Standard No.
- DIN EN ISO 13485:2021
- Release Date
- 2021
- Published By
- German Institute for Standardization
- Status
- 2019-11
- Replace By
- DIN EN ISO 13485 Berichtigung 1:2017
- DIN EN ISO 13485/A1:2019
- DIN EN ISO 13485:2016
- DIN EN ISO 13485:2021-12
- Latest
- DIN EN ISO 13485:2021
- DIN EN ISO 13485/A1:2019
- DIN EN ISO 13485:2016
- DIN EN ISO 13485:2021-12
- Scope
- This International Standard 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 and applicable regulatory requirements. Such organizations can
DIN EN ISO 13485:2021 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
