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Lindsey Folio, MS, MBA, RAC

President and Principal Consultant

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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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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