Professional Profile
About
With over 10 years of experience in the medical device industry, focuses on building and strengthening the foundation of QA/RA functions for startups and growing companies, ensuring that processes, documentation, and regulatory requirements are structured and scalable from early development through commercialization.
With a strong focus on EU MDR, support can be adapted to align with global regulatory requirements as companies expand into new markets.
Focus Areas and Expertise
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Implementation and development of Quality Management Systems (QMS) tailored to early-stage companies
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Technical documentation and technical file remediation to support regulatory readiness
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Preparation of technical files and support for regulatory submissions
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Specialized in European regulatory framework EU MDR
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Development and improvement of QA/RA processes as organizations grow
I work closely with teams to provide practical, hands-on support, helping establish structure while keeping solutions realistic and aligned with the pace of growing organizations.