Vice President – Regulatory
Mr. Sigmund has over 20 years medical regulatory compliance experience working with the U.S. FDA and other world regulatory bodies. His experience includes positions building biological medical devices as a Product Manager, Scientific Advisor for the Clinical Research, and as Director of Regulatory Affairs. Mr. Sigmund’s key clinical research has included studies of usability, precision, matrix and clinical drug and compound sensitivities, and multiple Food & Drug Administration 510k device submissions primarily focused on Blood Products, Blood Compounds, and Behaviors of Analytics and Chemical Indicators for the same. He has successfully complete multiple clinical studies and developed regulatory compliant documentation and submissions to assure FDA acceptance of research findings, as well as FDA acceptance of study designs, and the FDA monitoring and documentation for reporting of device design, changes, device performance, and study exception handling for diagnostic and prognostic Blood indications. Mr. Sigmund’s experience also included a blood gas device as well as Blood-Protein behavior protocols as included in his designs of Blood Sampling and Testing factors. Mr. Sigmund’s typical multi-function work teams included scientists, chemists, engineers, designers, mathematicians, physicians, clinical research associates and the extended business teams. Mr. Sigmund has degrees in biology and medical technology.