$81
CEI CEN/TR 17223
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
- Format:
- Language(s) :
- Published :
- English
- 05/01/2019
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.
| CEI CEN/TR 17223 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | CEI CEN/TR 17223 |
| Scope | 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 |
| Publisher | CEI - Comitato Elettrotecnico Italiano |
| Languages | English |
| State | [ Active ] |
| Publication Year | 2019 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| Edition | 19 |
| File Size | 1 file , 620 KB |
| Number of Pages | 88 |
| Published | 05/01/2019 |
| CEI CEN/TR 17223 | ||
|---|---|---|
| History | Publisher Year | |
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