SIS-CEN/TR 17223 : 2018
Current
Current
The latest, up-to-date edition.
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
Available format(s)
Hardcopy
Language(s)
Swedish - English
Published date
04-02-2019
Publisher
€122.94
Excluding VAT
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
| Committee |
JTC 3
|
| DocumentType |
Standard
|
| Pages |
0
|
| ProductNote |
THIS STANDARD IS REFERES TO : EN ISO 13485 : 2016
|
| PublisherName |
Swedish Standards
|
| Status |
Current
|
| Standards | Relationship |
| CEN/TR 17223:2018 | Identical |
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