Callie has overall responsibility for Acertara’s quality management system and our compliance with ISO13485:2016 certification and IEC/ISO 17025:2017 accreditation. In 2021, under her leadership, Acertara also achieved FDA ASCA accreditation for testing to sections of IEC 60601-2-37 and IEC 60601-2-5. She has more than 10 years of medical device QA/RA leadership in internal auditor training and quality system documentation development. At Acertara Callie also leads supplier qualification and provides consulting to Acertara customers on QMS implementation, and FDA 510(k) submission development and review. Callie is the Management Representative for ISO and FDA audits.
Callie Moore earned her Master of Science Degree in Regulatory Affairs from the George Washington University School of Health Science. Ms. Moore is Regulatory Affairs Certified (RAC) by the Regulatory Professional Affairs Society (RAPS) and the Acertara representative to the Medical Imaging & Technology Alliance (MITA/NEMA) Technical and Regulatory Committee.