The assessment of the execution of clinical evaluation and clinical investigation in the EU is subject to the Directives. With the new IVD Regulation and 5-year transition, manufacturers need to be prepared now to meet the requirements in place when their device is being assessed for certification. In order to avoid rework and time needed for re-submission, it’s critical to start establishing processes that align with the new requirements as soon as possible.
In this 60-minute session, presented in front of a live audience August 18, 2016, Sue Spencer, Head of Global Medical Device Services, shared her experience on what exactly has changed, what that means for device manufacturers, how to address existing devices that now fall under the regulation and how the Notified Bodies will approach the updated requirements.
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About the Presenter: Sue Spencer, Head of Global Medical Device Services at UL
Sue Spencer has over 30 years’ experience in the IVD industry 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 IVD and Medical Devices Directives and is now involved with the development of the new regulation.
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.