Full Description BS PD CEN/TR 17223:2018 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.
Cross References:
ISO 13485:2016
BS EN ISO 13485:2016
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