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BS PD CEN/TR 17223:2018
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BS 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
standard by BSI Group, 03/21/2018
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BS PD CEN/TR 17223:2018 provides guidance on the relationship between EN ISO 13485:2016, Medicaldevices - Quality management systems - Requirements for regulatory purposes and the requirementsin EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro DiagnosticMedical Devices.Cross References:
ISO 13485:2016
BS EN ISO 13485:2016
All current amendments available at time of purchase are included with the purchase of this document.