Shelsea Stone
Clinical Evaluations Manager @Merit Medical Systems, Inc.
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WORK HISTORY
Clinical Evaluations Manager @Merit Medical Systems, Inc.
EDUCATION
Brigham Young University
Bachelors, English/editing
SKILLS
ABOUT SHELSEA STONE
Senior Clinical Evaluation Report (CER) Manager with over 10 years of experience authoring, managing, and consulting on various clinical evaluation projects for the EU and China. Over a decade of medical writing and editing experience for scientific publications and regulatory documents. Author and project manager for CERs, Clinical Evaluation Plans (CEPs), Post-market Surveillance (PMS) Plans, Post-market Clinical Follow-up (PMCF) Plans, Summary of Safety & Clinical Performance (SSCP) reports and Periodic Safety Update Reports (PSURs) for major industry clients. Capable of analyzing medical device documentation for MDR gap assessment due to a thorough knowledge of MDD 93/42/EEC, MEDDEV 2.7/1 Rev 4, MDCG, and EU MDR (2017/745) requirements.
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