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

$199.00$398.78

Description

Standard By:BSI Group , 03/21/2018

Published:03/21/2018

Pages:88

ISBN(s):9780580519123

File Size:1 file , 940 KB

Language:English

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, Medicaldevices - Quality management systems - Requirements for regulatory purposes and the requirementsin EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro DiagnosticMedical Devices.Cross References:ISO 13485:2016BS EN ISO 13485:2016

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