About
Our Mission
Qualomics mission is to add value.
We want Quality to be a valuable and valued part of your business and we work to make that happen.
Qualomics was formed to provide quality and regulatory assistance to medical device start-ups and small companies where resources are limited and timelines are tight. We offer services for implementation of new FDA or ISO quality systems, inspection preparation, transfer to manufacturing, or internal auditing. We believe that a successful quality system works for you and integrates operations, quality and regulatory.
Our Founder
Founder Erica Livingston received a B.S. in Biology from the University of California, San Diego in 2002. She worked at the bench in assay and product development at the Salk Institute for Biological Studies, Johnson & Johnson Pharmaceutical Research, Hologic, and several start-ups before transitioning into quality system management. Erica has been in QA since 2008 and specializes in quality system development, implementation, and maintenance.
Erica earned the US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society. She also holds certificates in ISO 14971 Risk Management, MDSAP, verification and validation, and Lead Auditor for ISO 13485:2016.
In addition to extensive experience with ISO and FDA medical device requirements, Erica has experience with LDTs, CLIA/CAP accreditation, tissue banking standards, and clinical laboratory requirements.
Erica started in commercial assays and diagnostics and has developed into a collaborative leader in the development and production of electromechanical devices, injection-molded parts and devices, catheters, hand tools, assay readers, and combination products.
Erica brings a deep understanding of operations and the burden a quality system can place on a company if it is not implemented correctly. Her experience with operations allows her to define processes that work. She brings her vision of ensuring the quality system adds value to the organization while maintaining regulatory compliance.