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Homepage>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

sklademVydáno: 2018-03-21

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

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Označení normy:	PD CEN/TR 17223:2018
Počet stran:	88
Vydáno:	2018-03-21
ISBN:	978 0 580 51912 3
Status:	Standard

DESCRIPTION

PD CEN/TR 17223:2018

This standard 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 is classified in these ICS categories:

03.100.70 Management systems
11.040.01 Medical equipment in general

This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.

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