Christine Zomorodian

Christine Zomorodian

Gish Consulting

Innovative consulting in biomedical industries with emphasis on quality systems; process assessment, requirements and improvement; regulatory affairs; program and project management; compliant product development; quality data and metrics; technical writing and clinical skills.

Specialties: Quality Systems architecture, development and remediation, startups and acquisitions, Lean Sigma, program & process development, audit and inspection readiness, ISO/IEC standards compliance, report writing, regulatory submissions, CAPA & supplier quality programs, contamination, validation (HF & usability) and verification test design, and guidance interpretation in a regulated environment.

Working knowledge in FDA QSR & cGMP, EU MDD/MDR/MEDDEV, CMDCAS, IMDRF, ISO 13485/9001/14971/17025, MDDS, GAMP, ICH, Value Stream, Kaizen, IEC 60601-1/62353/62366, DSHEA, HACCP, CLIA, Health IT, applied statistics, and other assorted industry standards.

Familiar with numerous business and industry-specific software applications and platforms.