Ezgi T.

@ezgi_ozekinci_t

Medical Device QA RA Consultant ISO 13485 IEC 62304 MDR FDA Cybersecurity

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Über mich

I am a Medical Device QA/RA Consultant with hands-on experience in ISO 13485, EU MDR, FDA-oriented documentation, IEC 62304 software validation, and ISO 14971 risk documentation. I support medical device manufacturers, startups, and consultants through structured written communication, document review, gap assessment, and compliance-focused recommendations. My work is practical, detail-oriented, and focused on traceability, consistency, and audit readiness.... Mehr lesen

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