Qualomics LLC
About
Qualomics LLC provides quality and regulatory consulting for medical device start-ups and small companies. Our mission is to add value to your organization with practical, right-sized quality systems. For organizations that don’t yet have a dedicated quality or regulatory department, Qualomics helps meet FDA and ISO requirements without the overhead built for a much larger company.
Founder Erica Livingston, RAC, holds a B.S. in Biology from UC San Diego and has worked in medical device quality assurance since 2008, following a background in bench-level assay and product development at organizations including the Salk Institute, Johnson & Johnson Pharmaceutical Research, and Hologic. She holds the US Regulatory Affairs Certification (RAC) and certificates in ISO 14971 Risk Management, MDSAP, verification and validation, and Lead Auditor for ISO 13485:2016.
Qualomics works with companies developing electromechanical devices, injection-molded parts, catheters, hand tools, assay readers, diagnostics, and combination products — integrating quality, regulatory, and operations so the system supports the business rather than working against it.
Our mission is to add value to your organization.
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QUALITY SYSTEM CONSULTING
Strategic planning, QA operations, QMS development and implementation, off-the-shelf and custom SOPs, fractional quality management
WORKING WITH
Electromechanical Devices • Contract Manufacturers • Injection Molding • CNC/Lathe Machining • Reagents & Kits • Sterile Single-Use Devices • Consumer Goods
AUDITING
Internal audits, audit preparation, FDA inspection readiness, supplier and vendor audits, audit response and remediation
VALIDATION
Process validation, equipment IQ/OQ/PQ, software validation, validation protocols and reports
ADVERSE EVENT REPORTING
Electronic eMDR reporting via ESG NextGen
CERTIFICATIONS
US RAC, Lead Auditor ISO 13485:2016, ISO 14971 Risk Management, MDSAP, ISO 9001 and ISO 15189