Sue Spencer has 30 years experience in the IVD industry, and has held positions in R&D, Manufacturing and Quality Assurance. Sue has working in the Notified Body arena since the initial introduction of the IVD and Medical Devices Directives and is now involved with the development of the new IVD Regulation.
Sue has worked for BSI for over 5 years; she currently chairs the European Notified Body IVD Working Group coordinating the notified body responses to the changing regulatory environment. Sue also participates in the Commission IVD Technical Work Group as part of a sub group preparing guidance on the revised IVD classification.
Sue’s previous experience includes work as a consultant for 3 years during which time she set up her own consultancy, she then joined Abbott Diagnostics Division where she worked for 6 years as Manager for International Quality Systems and Risk Management for the Division.
In addition, Sue is an experienced tutor and regularly delivers interactive training for BSI using accelerated learning techniques for a variety of topics including the IVD Directive, ISO 13485 and risk management.