Medical Device Regulatory Compliance – Existing Directive versus proposed new Regulation
This is the second in the ongoing seminar series hosted by the Oxford Medical CE Marking Forum.
This presentation will provide an overview of the most significant changes and additions to the regulatory requirements for medical devices detailed in the proposed new regulation on medical devices which is expected to be published in early 2017.
Anne Jury is a regulatory affairs consultant with over 20 years’ experience in the medical and diagnostic healthcare technology industries. She has worked for Notified Bodies, BSI and then TÜV Product Service as a lead auditor covering over 200 medical companies worldwide.
Anne is a member of TOPRA, (The Organisation for Professionals in Regulatory Affairs) and RAPS, (Regulatory Affairs Professionals Society). She is active in the promotion of integrated quality management and regulatory systems to assist the successful introduction of new products to market. She has worked with companies ranging from non-profit organisations and research institutes to start-up university spin out companies, SMEs and multi-national market leaders.
12 December 2016, 9:00 (Monday, 10th week, Michaelmas 2016)
Botnar Research Centre, Headington OX3 7LD
Anne Jury (Anne Jury Associates)
Nuffield Department of Surgical Sciences
Dr Regent Lee (University of Oxford )
Organiser contact email address:
Members of the University only