Caitlyn Dzhafarov

Ms. Dzhafarov has extensive experience as a quality and regulatory professional with a diverse product portfolio in the regulated medical devices industry. With a background in quality systems, software quality engineering and regulatory affairs, Ms. Dzhafarov has made significant contributions toward the development and commercialization of unique device innovation.

Her experience has allowed her to bring critical and novel device technology to the global market, including the US, EU, Canada, S. Korea, Argentina, Australia, China, Japan, Brazil and Argentina. She has assisted organizations in achieving successful ISO 13485:2016 certification, MDSAP certification, FDA breakthrough device designation, 510(k) clearances, De Novo and CE marking, and has extensive experience developing 513g, presub, BDD, 510(k), De Novo, PMA, HDE, EUA and IDE/HREC submissions.

Ms. Dzhafarov is proficient in risk management, clinical/regulatory strategy, quality systems management, product project management, international standards and regulation gap analysis, software classification and validation, GDPR compliance, materials compliance, and general manufacturing engineering principals.