BS PD CEN/TR 17223

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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

Published by Publication Date Number of Pages
BSI 03/21/2018 88
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BS PD CEN/TR 17223 – 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

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 13485:2016
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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