Academic Credentials
  • M.S., Biomedical Engineering, Drexel University, 2009
  • B.S., Biomedical Engineering, Drexel University, 2004
Licenses & Certifications
  • ISO 14155:2020 Medical Device Standard from Biopharma Institute

Ms. Ciccarelli's has over 20 years of experience in medical device consulting that spans the total product lifecycle. She has extensive experience in establishing international medical device retrieval programs in accordance with ASTM F561 and ISO 12891. She develops customized programs and procedures regarding the collection, investigation, and analysis of devices in the context of marketing applications (e.g. IDE studies), post approval studies, and as part of post market surveillance (e.g. 522 orders) and quality management activities. In addition, she assists clients with a variety of preclinical testing programs to support a number of research and development and regulatory objectives. 

Ms. Ciccarelli is experienced in training internal client teams and external clinical investigation sites in retrieval programs in compliance with ISO 14155, Clinical investigation of medical devices for human subjects — Good Clinical Practice.