SN-CEN/TR 17223:2018 PDF

SN-CEN/TR 17223:2018 PDF

Name:
SN-CEN/TR 17223:2018 PDF

Published Date:
03/21/2018

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:
Standards Norway SN-CEN/TR Series

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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ADOPTED_FROM:CEN/TR 17223:2018

This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.


Number of Pages : 88
Published : 03/21/2018

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