Principal Consultant
RQM+
Anike Freeman received her B.S. in Bioengineering from the University of Maryland, College Park. Upon graduation, she began working at FDA as a research fellow in the Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH), and then transitioned to working as a biomedical engineer and reviewer in what is now the Office of Product Evaluation and Quality (OPEQ). She primarily reviewed 510(k)s and pre-submissions for various dental devices such as orthodontic appliances, restorative materials, dental implants, and bone grafting materials. While working, Anike earned her M.Eng. in Bioengineering from the University of Maryland, College Park, and also transferred to CDRH's Division of Industry and Consumer Education (DICE) as a Consumer Safety Officer. She educated industry on how to comply with U.S. medical device regulations and served as the DICE subject matter expert for medical device adverse event reporting, 510(k)s, and dental devices. She was later promoted to Senior Consumer Safety Officer where she managed division operations for several years. During this time, she received the CDRH Lireka P. Joseph Award for Excellence in Public Health Communication and Education.
Anike completed the Professional Project Management Certificate Program through an FDA partnership with Strategy Execution and Duke Corporate Education, and went on to earn her project management certification. She brings 10 years of FDA experience to RQM+.
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Tuesday, September 13, 2022
1:30 PM – 2:00 PM MST