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Who We Are

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. 

Our team is led by Lindsey Folio, a RAC Certified Regulatory Affairs professional with both an MBA and MS in Bioengineering. Lindsey Folio has over 15 years of experience ensuring regulatory compliance for medical device companies. She is an excellent problem solver and leader, who understands business and marketing strategies, but has the engineering background to enable effective communication with technical teams. 

Lindsey has successfully developed regulatory strategies for Class I, II, and III medical devices, IVDs and combination products. She is experienced at completing 510(k)s, PMA and PMA supplements, IDE, HDE/HUD, FDA Pre-Submission meeting requests, EU MDD Tech Files, Design Dossiers, and Technical Documentation for EU MDR. Lindsey has developed Quality Management Systems and Risk Management Procedures for clients, to ensure compliance with 21 CFR Part 820, ISO 13485, and ISO 14971. She has led meetings with FDA to discuss topics such as regulatory strategy, device risk, device down-classification (de novo), and human factors studies. Lindsey has supported engineering, manufacturing, and clinical teams through the design control process; offering regulatory expertise during design input & output creation, verification, validation, design transfer, pre-clinical, and clinical testing.

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.

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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