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Meet the Team

Let us help you navigate the medical device industry.

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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

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Moving us forward

"I'm passionate about ensuring that innovation meets the regulation, so that every medical device can reach its full potential in improving patient lives."

Dustin Folio, JD

Vice-President and Consultant

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Putting it together

"My purpose is to execute on the our team’s strategy by turning ideas and problems into tangible results and solutions."

Kurin Williams, MBA

Business Manager and Regulatory Specialist

Who We Are

Folio Consulting Group, LLC (FCG) is a boutique Regulatory Affairs consulting firm, who specializes in guiding medical device companies through the complex regulatory landscape. We offer expert Regulatory Affairs and Quality consulting services for medical device companies. At Folio Consulting Group, LLC, we understand that navigating the requirements of the medical device industry is not always easy. We are here to serve as your partner, by translating complex regulations into actionable strategies for your business. 

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Our team is led by Lindsey Folio, a distinguished regulatory affairs consultant specializing in guiding medical device companies through the intricate process of securing US FDA clearances or approvals. As a RAC Certified Regulatory Affairs Professional with over 15 years of experience ensuring regulatory compliance for medical device companies, Lindsey brings a wealth of knowledge and expertise to her clients. Her professional journey is marked by a deep understanding of the regulatory landscape, enabling her to provide strategic advice and hands-on support in navigating the complexities of medical device regulations. Lindsey’s ability to synthesize technical details with regulatory requirements ensures that her clients not only meet compliance standards but also achieve successful market entry.

 

Throughout her career, Lindsey has demonstrated exceptional skills in regulatory strategy development, submission preparation, and quality system compliance. Her proactive approach and keen eye for detail have been instrumental in her clients’ achievements, from early-stage startups to more established entities seeking to expand or modify their product offerings.

 

Lindsey is experienced at completing 510(k)s, PMAs and PMA supplements, IDEs, HDE/HUD, FDA Pre-Submissions, Technical Files, Design Dossiers, and Health Canada License Application. She is well-versed in Quality Management Systems and Risk Management, ensuring compliance with 21 CFR Part 820, ISO 13485, and ISO 14971. Lindsey has led many meetings with FDA to discuss topics such as regulatory strategy, device risk, performance testing requirements, device down-classification (de novo), and human factors or clinical studies.

 

Lindsey loves working with engineering, manufacturing, marketing and clinical teams to support them through the design control process; offering regulatory expertise during design input & output creation, verification, validation, design transfer, pre-clinical, and clinical testing. She is dedicated to staying abreast of evolving regulations and committed to excellence, which makes her a trusted partner for any medical device company aiming to navigate the regulatory landscape successfully.

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FCG is also supported by Dustin Folio, JD who has been working in the medical device industry as a Regulatory Affairs Professional for over 7 years. During this time he has worked on Class I, II, and III devices performing both pre-market and post-market activities for companies ranging from small startups to fortune 500 companies. He has helped several companies navigate the complete design control process; providing regulatory support from device conception through regulatory submission and launch, as well as post-market changes, maintenance, and renewals. Dustin has extensive experience with both US and EU MDR regulations, as well as many LATAM, Middle Eastern, and South American geographies, plus Canada and Australia/New Zealand.

 

Contact FCG today to set up your free 30-minute initial consultation to see how we can help unlock the medical device market for you.

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With a deep understanding of regulatory requirements, we make premarket submissions easy.

Click to schedule a free 30 minute initial consultation to see how we can help craft your regulatory strategy. 

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