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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
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RAPS Focus
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Networking Opportunity
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Ticketed Event
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Student Focus

Sue Spencer

Director
Compliance-Connextions Limited
Farnborough, England, United Kingdom

Sue has over 39 years’ experience in the IVD and Medical Device industries including extensive notified body experience.
Key areas of expertise include, IVDR and UK MDR regulations, QMS implementation and risk management including the development of training and coaching of regulatory and quality staff to improve their systems to meet both regulatory and business needs.
Sue has worked for several IVD companies ranging from start up to large multinationals holding positions in R&D, manufacturing, quality assurance and risk management this enables a holistic perspective to support growing companies.
Sue worked for three UK based Notified Bodies establishing two from scratch. During this time, she chaired the IVD Notified Body Working Group to coordinate Notified Body input to the Commission IVD Working Group who developed Common Specifications and guidance.
Sue established Compliance Connextions in Nov 2024 to support the IVD industry meet regulatory and quality requirements primarily for EU and UK market access.
Sue is Co-Chair of the IVD Members Group at the Association of British HealthTech Industries (ABHI) a UK trade association.

Presentation(s):

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