Professional Profiles

Erika B. Ammirati, RAC, is an independent regulatory consultant to industry located in Los Altos, CA. Ms. Ammirati specializes in the areas of clinical trials and product approvals for diagnostics and devices, with an emphasis on point-of-care (POC) and over-the-counter diagnostics. She is also well-versed in CLIA regulations and has brought several POC diagnostics through the CLIA wavier process.

Prior to becoming a consultant thirteen years ago, Ms. Ammirati gained over 10 years industry experience in in-vitro diagnostic (IVD) firms, preceded by a 10-year career in the clinical laboratory as a medical technologist.

Ms. Ammirati is the author or co-author of numerous publications, and holds a BS degree in Genetics from the University of California, Davis, and current California State licensure in Medical Technology. She is also certified as a regulatory professional through RAPS (Regulatory Affairs Professional Society).