CEI CEN/TR 17223
Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
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| Organization: | CEI |
| Publication Date: | 1 May 2019 |
| Status: | active |
| Page Count: | 88 |
| ICS Code (Medical equipment in general): | 11.040.01 |
| ICS Code (Management systems): | 03.100.70 |
scope:
This Technical Report provides guidance on the relationship between EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices.
Document History
CEI CEN/TR 17223
May 1, 2019
Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
This Technical Report provides guidance on the relationship between EN ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes and the requirements in EU...