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Date: 31 October 2023 

What is the webinar about?

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.

Who should attend?

Manufacturers who design and manufacture IVD devices incorporating software and/or standalone IVD software.

What will participants gain?

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.

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.

Dr Elizabeth Harrison is BSI's Global Head of In Vitro Diagnostics. She is responsible for operational delivery of technical documentation review and certificate decisions for IVDD, IVDR and UKCA.

Before joining BSI in 2014, she held senior and principal scientist roles in design and development of NAT diagnostic platforms for near-patient testing of sepsis, respiratory infections, genetic disease, cancer and companion diagnostics.

She also spent time as a post-doctoral scientist in the School of Translational Medicine at the University of Manchester investigating rapid diagnostics for sepsis and respiratory disease. Liz holds a BSc (Hons) in Biochemistry and a PhD in molecular diagnostics.

Thomas has over 20 years’ experience in Research and Development of AIMD products specifically in the field of neuromodulation. He has an in-depth knowledge of Biomedical Engineering, Biomedical Microsystems and Medical Engineering. He also has great experience in Neuroprosthetics, which includes micro-structuring, manufacturing, wireless energy and signal transmission as well as the characterisation of active implantable systems.

Thomas leads a global team of 22 Product Technical Specialists and dedicated clinical experts, who are not just experienced in the regulatory process, but who are product experts who understand the specifics of active implantable products.