Artificial intelligence – one more challenge for IVDR compliance; supported by Johner Institute

As the IVD industry explores and exploits the potential of emerging technologies, Notified Bodies and Competent Authorities are obliged to tighten existing regulations to maintain oversight and ensure an appropriate level of safety and performance for the marketed products.

This Deep Dive session is an open debate with the participation of the Johner Institute intended to tackle approaches for addressing the increasing complexity of regulatory requirements manufacturers of AI-based IVD medical device software are subjected to.

External speaker: Dr Catharina Bertram, Johner Institute, supports IVD manufacturers by advising on strategic issues and contributing to creating the technical documentation of IVD medical devices. Her focus is on IVD assays and IVD software, particularly AI-based software. She is an expert in the performance evaluation of IVDs.

Date and time: Thursday, 27 October 2022, 7.00 pm (CEST) / 1.00 pm (EDT)

Your speakers: Dr Alexander Stock, Project Manager In Vitro Diagnostic Medical Device Testing

Dr Kenneth Fuh, Product Assesment Expert

Dr Catharina Bertram, Johner Institut

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