Andrew Zekakos

I’m a Quality Assurance and Regulatory Affairs specialist with broad experience in medical laboratories, SaMD environments, and in vitro diagnostic regulation. I focus on building and maintaining compliant QMS frameworks that hold up under evolving digital health expectations.

In my current role as a Quality & Regulatory Affairs Associate, I support end-to-end compliance activities for SaMD under EU Advisory and contribute to structured regulatory pathways for new software development. I work closely with stakeholders to ensure alignment with MDR and FDA regulatory frameworks.

My quality approach is rooted in structured problem-solving—paired with clear communication, attention to detail, and practical execution. I’ve contributed to the development and maintenance of ISO documentation and processes, including ISO 13485:2016 and ISO 27001:2022, and I coordinate regulatory planning to improve cross-functional readiness.

Previously, as a Quality Assurance Specialist, I oversaw compliance with ISO 15189, ISO 9001, and ISO 27001, ensuring audit-readiness and continuous adherence to accreditation standards. I also supported IVDR certification and CAP Laboratory Accreditation requirements, and—because I come from a clinical lab background—I’m comfortable driving QA/QC activities like method verification, equipment performance review, and internal/external proficiency testing.