PD CEN/TR 17223:2018 PDF
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
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
- Статус документа:
- D
- Формат:
- Электронный (PDF)
- Дата публикации:
- 31 марта 2018 г.
- ICS:
- 03.100.70
- SKU:
- PD CEN/TR 17223:2018
Abstract
What is PD CEN/TR 17223 - Relationship between EN ISO 13485: 2016 and European and in vitro diagnostic medical devices regulation about?
PD CEN/TR 17223 discusses 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 guides on the relationship between EN ISO 13485:2016 , medical devices – quality management systems – requirements for regulatory purposes, and the requirements in EU Regulation 2017/745 on medical devices and EU regulation 2017/746 on in vitro diagnostic medical devices. As the requirements are integrated and built on each other, all the requirements under PD CEN/TR 17223 apply to the organizations’ activities and the applicable regulatory requirements need to be applied. Note: It is not intended that requirements be implemented in isolation from the complete system.
Who is PD CEN/TR 17223
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