Meet the Team
Let us help you navigate the medical device industry.
Leading our team
"Providing unparalleled regulatory strategy and executional leadership to our medical device clients is my passion. I thrive on leveraging the efficiencies of our team to guide clients toward successfully securing market authorizations.”
Lindsey Folio, MS, MBA, RAC
President and Principal Consultant
Who We Are
We are a team of regulatory affairs and quality systems experts dedicated to helping medical device innovators bring impactful technologies to market with clarity, efficiency, and purpose.
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By transforming regulatory uncertainty into structured, actionable strategies, we guide startups and growth-stage companies through FDA and EU regulatory pathways, including 510(k), De Novo, PMA, Q-Submissions, and MDR technical documentation, with confidence.
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Rooted in technical engineering expertise, paired with deep regulatory insight, we partner closely with our clients to deliver regulatory and quality services. Whether developing a regulatory roadmap, building a compliant quality system, or writing a regulatory submission, our support allows our clients to navigate and overcome the complexity.
​
At Folio Consulting Group, we see regulatory strategy as a powerful lever for innovation, and a trusted pathway to bringing meaningful technologies to the patients and clinicians who need them.
Who We Are
We are a team of regulatory affairs and quality systems experts dedicated to helping medical device innovators bring impactful technologies to market with clarity, efficiency, and purpose.
​
By transforming regulatory uncertainty into structured, actionable strategies, we guide startups and growth-stage companies through FDA and EU regulatory pathways, including 510(k), De Novo, PMA, Q-Submissions, and MDR technical documentation, with confidence.
​
Rooted in technical engineering expertise, paired with deep regulatory insight, we partner closely with our clients to deliver regulatory and quality services. Whether developing a regulatory roadmap, building a compliant quality system, or writing a regulatory submission, our support allows our clients to navigate and overcome the complexity.
​
At Folio Consulting Group, we see regulatory strategy as a powerful lever for innovation, and a trusted pathway to bringing meaningful technologies to the patients and clinicians who need them.
