Session Tracks covered by Evangeline
Talks covered by this speaker
3
Prioritizing Documentation for MDR Transition Planning
Connect with Evangeline
About this Speaker
During her over 13 year tenure at Emergo, Evangeline has assisted hundreds of manufacturers with global regulatory strategy, registration and consulting projects. Evangeline's areas of expertise include European CE Marking, clinical evaluation reports, and now performance evaluation reports, global vigilance, and device classification in markets worldwide. She has been intimately involved in the transition from the Directives to the Regulations, and all the related regulatory requirements. Evangeline is a key architect in developing tools for Emergo’s Regulatory Affairs Management Suite (RAMS) software. She previously worked for Cook Medical as a regulatory scientist and at a non profit lobbying for medical schools. She has her Regulatory Affairs Certification, US and EU, holds a Ph.D. in pharmacology from The University of Texas Health Sciences Center at San Antonio, and a B.S. in microbiology from Cornell University. While she has no spare time, if she did, she would enjoy contemplating methods of how to be more efficient, working-out as a means to enjoy food, and traveling for leisure.
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