Karen Elizondo is a practicing Medical Doctor with 19 years of clinical experience, including 15 years spent teaching and leading research projects in academic settings. Today, she combines her medical background with regulatory writing responsibilities. She develops key regulatory documents including Clinical Evaluation Reports (CERs), Summaries of Safety and Clinical Performance (SSCPs), PMCF Plans and Reports, and Periodic Safety Update Reports (PSURs). Karen also oversees clinical studies across multiple locations, ensuring compliance with Good Clinical Practices and the expectations of MDR, FDA, TGA, and Health Canada.