Instruments / Software-specific requirements under IVDR

The scope of the new European regulation has been expanded to include software and systems. The general safety and performance requirements (GSPR) presented in Annex I further enhance the requirements associated with stand-alone software or embedded software and instruments for all classes.

This session reviews the new requirements introduced by the IVDR. Together with our experts we will deep dive into solutions that could be used to meet these requirements and review applicable testing for such products, such as IEC 61010, cyber security testing and EMC testing.


Date and time: Thursday, 20 May 2021, 10.30 am (CEST)

Your speakers: Dr Julien Senac, Global Director IVD

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