IVDR conformity assessment

The European IVD Regulation covers reagents, kits, instruments and stand-alone software. All these products must comply with the General Safety and Performance Requirements presented in Annex I. This webinar reviews how to determine the requirements applicable to various devices and discusses tests to be conducted by manufacturers to demonstrate compliance (i.e.: IEC 61010-2-101, cyber-security, packaging, transportation, etc...).    


Date and time: Thursday, 11 November 2021, 4.30 pm (CET)

Your speaker: Dr Julien Senac | Global Director IVD 

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