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Homepage>BS Standards>03 SOCIOLOGY. SERVICES. COMPANY ORGANIZATION AND MANAGEMENT. ADMINISTRATION. TRANSPORT>03.100 Company organization and management>03.100.70 Management systems>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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immediate downloadReleased: 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

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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Standard number:PD CEN/TR 17223:2018
Pages:88
Released: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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