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Carolyn Guthrie

Carolyn Guthrie

Regulatory Affairs Certificate (RAC) US

Director of QA / RA
Kapstone Medical

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About this Speaker

Carolyn has 15 years’ experience in quality assurance and regulatory affairs in the Medical Device industry. She has worked for and with both large corporations and start-up companies with a single employee. The types of devices she has worked with has varied from In Vitro Diagnostic devices to Orthopedic and Dental implants, and from Software products to Packaging and Sterilization solutions. Carolyn has experience globally, with a focus on North America and Europe, in both the pre-market and post-market quality and regulatory functions, including pre-market submissions (510(k) and CE Mark), as well as day-to-day operations in quality assurance and quality systems.

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