I have over 25 years of professional experience, including working for IVD manufacturers, clinical laboratories, and the US Food and Drug Administration (FDA). I have extensive clinical and regulatory experience in in vitro diagnostics (IVD), and have also designed and implemented Laboratory Developed Tests (LDTs). I have planned, executed, and managed clinical trials to generate data for regulatory submissions, and developed a Good Clinical Practice (GCP) quality system for an IVD manufacturer. I lead the integration of the CLIA certification requirements into an ISO 9001 / ISO 13485 certified facility, and integrated the Quality System Regulation requirements into a CLIA certified clinical laboratory in anticipation of FDA’s regulation of LDTs. I currently oversee quality and regulatory for OpGen's CLIA certified clinical laboratory, as well as quality and regulatory for OpGen's medical device division.