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CEI CEN/TR 17223 PDF

CEI CEN/TR 17223 PDF

Name:
CEI CEN/TR 17223 PDF

Published Date:
05/01/2019

Status:
[ Active ]

Description:

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:
Comitato Elettrotecnico Italiano

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$48.9
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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.


Edition : 19
File Size : 1 file , 620 KB
Number of Pages : 88
Published : 05/01/2019

History

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