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

BSI Group, 03/21/2018

Publisher: BS

File Format: PDF

$189.00$378.46


Published:21/03/2018

Pages:88

File Size:1 file , 940 KB

Note:This product is unavailable in Ukraine, Russia, Belarus

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.

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