Medical Device Seminar Series – EU Regulatory Environment
In the ever-changing world of regulatory affairs, it’s critical that companies stay up-to-the-minute on the requirements to bring a product to market. LifeSciences BC was therefore pleased to offer this event designed to provide the latest information on the regulatory environment in the EU, and review important recent changes made to it. This discussion was led by Dr. Evangeline D. Loh, Director of Regulatory Affairs, Emergo Group, Inc., and included the following areas:
- Medical Devices and CE Marking in 2008
- Directive 2007/47/EC Modifications to the Medical Devices Directive
- Vigilance
Speaker Profile
Evangeline D. Loh, Ph.D., RAC
Director of Regulatory Affairs
Emergo Group, Inc.
Dr. Evangeline Loh oversees regulatory consulting support for Emergo clients worldwide, and oversees Emergo's European Authorized Representative clients. Prior to joining Emergo Group, Dr. Loh was involved in regulatory affairs for the surgery and critical care units of Cook, Inc. She has extensive knowledge of US and EU regulations, in addition to working on regulatory submissions around the world. Prior to her tenure at Cook, Dr. Loh worked for the Division of Biomedical Sciences at the Association of American Medical Colleges (AAMC) in Washington, DC. Her role there was to develop data metrics and quality control measures, conduct statistical analysis to evaluate the performance of clinical sites, and to manage graduate education policy. As a graduate student at the University of Texas Health Science Center at San Antonio, Dr. Loh designed and implemented research protocols to conduct experimental research using complex molecular techniques. She obtained a BS in Microbiology from Cornell University, a PhD in Pharmacology from the University of Texas Health Science Center at San Antonio, and holds the RAC (US, EU) designation from the Regulatory Affairs Professional Society.

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