SIS-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
SIS-CEN/TR-17223
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2018 EDITION
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CURRENT
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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.
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11.040.01 (Medical equipment in general)
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Designation Name
SIS-CEN/TR 17223:2018
Revision Level
2018 EDITION
Status
Current
Publication Date
March 28, 2018
Language(s)
English
Page Count
96