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System Supervision
System Supervision, Total:21 items.
In the international standard classification, System Supervision involves: Medical equipment, Company organization and management, Quality.
US-FCR, System Supervision
Danish Standards Foundation, System Supervision
- DS/EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
- DS/EN ISO 13485:2021 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
- DS/EN ISO 13485/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
Association Francaise de Normalisation, System Supervision
ES-UNE, System Supervision
- UNE-EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- UNE-EN ISO 13485:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
Standard Association of Australia (SAA), System Supervision
- AS ISO 13485:2017 Medical devices — Quality management systems — Requirements for regulatory processes
Canadian Standards Association (CSA), System Supervision
- CAN/CSA-ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (Second Edition)
German Institute for Standardization, System Supervision
- 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
- 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
- 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
RU-GOST R, System Supervision
- GOST ISO 13485-2011 Medical devices. Quality management systems. System requirements for regulatory purposes
Lithuanian Standards Office , System Supervision
- LST EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003+Cor.1:2009)
- LST EN ISO 13485:2012/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor.1:2009)
AENOR, System Supervision
- UNE-EN ISO 13485:2013 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)