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What’s New in Devices: European Medical Device Regulations and MDUFA IV
Session Chair(s)
Angela Stokes, MSC
Vice President, Head Global Regulatory Consulting, Syneos Health, United Kingdom
With the new medical device and IVD regulations in the EU, plus the renewal of MDUFA in the USA, the year 2017 is a pivotal and disruptive period for medical device and diagnostic regulations. This session explores notable developments in global device regulation
Learning Objective : Summarize recent global device regulatory changes; Describe potential approaches for development and lifecycle management strategies to ensure future compliance.
Speaker(s)
Angela Stokes, MSC
Vice President, Head Global Regulatory Consulting, Syneos Health, United Kingdom
Are You Ready for the Medical Devices Regulation? What Should Manufacturers be Considering Now
Theresa Jeary, MSC
Head of Notified Body , Lloyds Register Quality Assurance (LRQA), United Kingdom
The EU Medical Device Regulations: The Notified Body View
LeeAnn L Chambers, MS
Principal Research Scientist, Global Regulatory Affairs, CMC - Devices, Eli Lilly and Company, United States
US Perspective
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