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Gain an overview of IVDR requirements for software and cybersecurity including IVD devices that incorporate software and IVD standalone software.
This webinar covers lessons learned from technical documentation reviews of IVD software and feedback on IVD software documentation assessments.
Approach to classification of IVD software.
How best to prepare technical documentation for IVD software.
BSI expectations of cybersecurity documentation of IVD software.
Specific feedback on IVD software technical documentation assessments performed so far.
Global Head of IVD Medical Devices, BSI
Global Head Active Implantable Medical Devices, BSI
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