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 |
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:
- This product is unavailable in Ukraine, Russia, Belarus