Head IVD Business Unit and UK Country Manager
Qserve Group, United Kingdom
Sue leads Qserve’s IVD Business Unit, she has over 38 years’ experience in the Medical Device and IVD industries including extensive notified body experience.
Key areas of expertise include
• IVDD and IVDR regulations
• QMS implementation
• Internal, supplier and compliance audits
• Risk Management
• CDx
• Training
• Working with small start-up and multinationals
• UK Regulations, QualRep part of the Qserve Group is a UKRP
Sue has worked for several IVD companies ranging from start up to large multinationals, where she has held positions in R&D, manufacturing, and quality assurance. Sue worked for 3 notified bodies establishing two from scratch.
Sue has worked for Qserve for 5 years helping manufacturers transition to the IVD Regulation and leading a team specialising in both European and FDA submission and quality systems, with special interests in CDx for IVDs.
Sue is Co-Chair of the IVD Members Group at the Association of British Healthtech Industries trade association.
Wednesday, September 18, 2024
2:15 PM – 3:15 PM PDT
Structured Dialogue for (IVD) Medical Devices in Europe: Now Will Finally Get Some Answers
Thursday, September 19, 2024
1:00 PM – 2:00 PM PDT