Overview

The webinar presents an overview of IVDR requirements for software and cybersecurity and will discuss IVD devices that incorporate software and IVD standalone software. Attendees will gain insights on BSI expectations of technical documentation for devices where these requirements apply.

Join this insightful webinar to hear subject matter experts, Dr Elizabeth Harrison, Global Head of IVD, BSI and Thomas Doerge, Global Head Active Implantable, BSI discuss BSI’s expectations of cybersecurity documentation of IVD software. In this webinar we will talk about lessons learned from technical documentation reviews of IVD software as well as specific feedback on IVD software technical documentation assessments performed thus far.

You will also gain a better understanding IVDR requirements for software and cybersecurity.

Key takeaways and learning objectives

The webinar will include:

• 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.

Presenter information

Speaker - Dr Elizabeth Harrison, Global Head of IVD Medical Devices, BSI

Speaker - Thomas Doerge, Global Head of Active Implantable Medical Devices (AIMD), Regulatory Services, BSI