Global Service Line Director – Regulatory - Underwriters Laboratories
WHAT'S HAPPENING WITH NOTIFIED BODIES?
Wednesday 24th of January 15:15 - 16:00
Sue Spencer has over 30 years experience in the Medical Device and IVD industries where she has held positions in R&D, Manufacturing and Quality Assurance; she has worked in the Notified Body arena since the initial introduction of the Medical Devices and IVD Directives and is now involved with the development of the new regulations.
Sue has over 10 years experience working for several Notified Bodies; she currently chairs the European IVD Notified Body Working Group coordinating the notified body responses to the changing regulatory environment. Sue also participates in the Commission IVD Technical Work Group and chairs a sub group preparing guidance on the revised IVD classification.
In the past Sue has worked as a consultant establishing her own consultancy before joining Abbott Diagnostics Division where she was Manager for International Quality Systems and Risk Management for the Division for over 6 years.
Sue is an experienced tutor on a variety of topics including the IVD Directive, ISO 13485 and risk management.