Following the call for nominations for the role of chair and vice chair for the AI/ML Software as an IVD subgroup, we have received two nominations. Please find below statements from the two candidates. If we receive no objections by Close of Business Friday 14th Feb 2025, the nominees will be appointed.
Tsz Wai Woo – IVDeology – Nominee – Chair/Vice Chair.
“Tsz Wai Woo started in the IVD industry 17 years ago, manufacturing of, and providing technical support for, IVDs for the diagnosis of infectious diseases and microbial identification for a large IVD medical device manufacturer. During this time, she was involved with providing supporting technical documentation to the Regulatory Affairs team, sparking her interest in Regulatory.
In 2016, Tsz Wai made the move to Regulatory Affairs and hasn’t looked back since. During this time, she was responsible for compiling technical files, conducting IVDR gap analyses on technical documentation & QMS procedures, product registrations, providing regulatory oversight during complaints and vigilance investigations, as well as change control and risk management meetings. She also provided Regulatory training and conducted internal audits.
Tsz Wai is now a Regulatory Affairs Consultant at IVDeology Ltd, having joined the team in September 2020. She enjoys helping clients to understand and navigate IVD regulations in the UK, EU and around the world. She has a pragmatic approach to finding the best solutions for clients, of different sizes and at different stages of design and development.
Tsz Wai has worked with a number of clients who are developing AI/ML software as an IVD, or at least incorporating AI/ML software into their device. She believes this is the time to get a broader understanding of AI/ML software and be involved in developing practical implementation strategies for regulatory approval and maintaining compliance.”
Prathibha Prasanna – Leica Biosystems – Nominee – Vice Chair.
Dear Members of the Regulatory Affairs Working Party,
I am writing to express my interest in serving as Vice Chair of the AI/ML SaIVD Subgroup at BIVDA. With extensive experience in software medical devices and IVDs regulatory affairs, I am well-positioned to contribute to the subcommittee’s efforts in navigating the evolving AI/ML landscape within in vitro diagnostics.
As a RAPS RAC Devices-certified professional, I bring a robust foundation in regulatory frameworks and compliance. I have successfully led technical submissions for Software as a Medical Device (SaMD) leveraging AI/ML, ensuring alignment with regulatory requirements while balancing innovation and safety. Currently, I am actively involved in the development of a novel AI IVD product, where I perform standards gap assessments and drive adherence to evolving regulations.
In addition to my technical expertise, I am engaged in shaping the broader regulatory environment through participation in key industry groups such as MedTech Europe’s AI/Software Working Party and the NEN Standards Committee for AI and Big Data. I regularly consolidate consultation feedback on behalf of my organization and provide thoughtful input to regulatory consultations, reflecting my commitment to shaping meaningful policy and guidance.
If elected as Vice Chair, I will bring:
- Regulatory and Technical Expertise with focus on advancing innovation responsibly
- Industry Insight with active involvement in industry-wide working groups ensuring access to up-to-date knowledge of trends, challenges and opportunities
- Collaborative Approach by gathering diverse perspectives and driving collective progress
I am passionate about ensuring that BIVDA’s AI/ML SaIVD Subgroup leads the way in addressing the unique challenges posed by AI/ML technologies. My aim is to support the Chair and members in facilitating proactive, discussions and initiatives that empower manufacturers to thrive in this changing regulatory landscape.
Thank you for considering my candidacy.
Prathibha Prasanna
