
Dustin Folio, JD
Vice-President and Consultant
With 8 years of experience in regulatory affairs within the medical device industry, Dustin is a skilled and detail-oriented professional dedicated to ensuring product compliance and facilitating timely market access across global markets. Over the course of their career, Dustin has developed deep expertise in navigating complex regulatory frameworks, including FDA (510(k), PMA), EU MDR, and other international regulatory requirements.
​
Dustin excels in preparing and managing regulatory submissions, developing strategies for market entry, and overseeing post-market activities. He has a strong track record of collaborating with cross-functional teams in R&D, quality, and manufacturing to ensure that products meet all regulatory standards throughout their lifecycle.
​
In addition to regulatory submission experience, Dustin has a proven ability to interpret evolving regulations, stay ahead of industry trends, and communicate regulatory insights to leadership and other departments. With a solid foundation in ISO 13485, 21 CFR Part 820, and other key medical device standards, he is adept at supporting companies in achieving both compliance and business objectives.
​
Dustin is passionate about helping innovative medical devices companies successfully reach the market and is commitment to maintaining the highest standards of compliance in an ever-changing regulatory landscape.