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BS PD CEN/TR 17223:2018

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

standard by BSI Group , 03/21/2018

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Full Description

BS PD CEN/TR 17223:2018 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.


Cross References:
ISO 13485:2016
BS EN ISO 13485:2016


All current amendments available at time of purchase are included with the purchase of this document.
 

Product Details

Published:
03/21/2018
ISBN(s):
9780580519123
Number of Pages:
88
File Size:
1 file , 940 KB
Product Code(s):
30368734, 30368734, 30368734
Note:
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