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Understanding IVDR Software and Cybersecurity - Asian scientist people in laboratory
  • Webinar
    Medical Devices

Understanding IVDR Software and Cybersecurity

Gain an overview of IVDR requirements for software and cybersecurity including IVD devices that incorporate software and IVD standalone software.

Incorporating software and/or standalone IVD 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.

Understanding IVDR Software and Cybersecurity

An overview of IVDR requirements for software and cybersecurity and will discuss IVD devices that incorporate software and IVD standalone software.

  • Dr Elizabeth Harrison, Global Head of IVD Medical Devices, BSI

  • Thomas Doerge, Global Head Active Implantable Medical Devices, BSI

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