Erica Livingston RAC, has been working in the biotech industry for over 15 years including 8 years of Medical Device experience with varied roles in Product Development, Process Development, Commercialization, Operations and Quality. In her recent role with Qualomics, LLC, Erica serves as the President where she consults with a variety of clients on Quality and Regulatory matters. She specializes in Quality System development and optimization including design control, production, corrective action and risk management. She is a Molecular Biologist who uses her bench experience to develop Quality, Manufacturing and Commercialization strategies for IVDs and LDTs. Her work includes design control, late stage development and transfer to manufacturing under ISO 13485 and 21 CFR part 820 for diagnostics, orthopedics, combination products and a variety of other devices. Erica has managed GLP and CLIA/CAP Accredited Quality Systems for clinical laboratories. Erica received her Bachelor’s of Science in Biology from University of California, San Diego. She holds certificates for auditing in ISO 13485, ISO 14971 and MDSAP and a credential in US Regulatory Affairs.