Standard Technical reports · SIS-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

Status: Valid

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Standard Technical reports · SIS-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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Price: 1 675 SEK
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Scope
This Technical Report provides guidance 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.

Subjects

Management systems (03.100.70) General (11.040.01)


Buy this standard

Standard Technical reports · SIS-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
Subscribe on standards - Read more Dölj
Price: 1 675 SEK
standard ikon pdf

PDF

Price: 1 675 SEK
standard ikon

Paper

Price: 2 680 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-80003261

Edition: 1

Approved: 3/28/2018

No of pages: 96