Sue Spencer

IVD Lead/ Principal Consultant
Qserve group, United Kingdom

Sue leads Qserve’s IVD service, she has over 37 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
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 3 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.

Disclosure information not submitted.

Presentation(s):

• CDx or Not CDx, That is The Question - The Impact of the Clinical Trial Regulation on Tests Used in Pharma Studies and Whether and How the IVDR Applies

  Thursday, May 11, 2023
  13:45 – 14:45 CEST

• Sponsored Presentations: FDA first, CE later. Clinical and regulatory strategy trends

  Friday, May 12, 2023
  13:15 – 13:45 CEST