Lindsey Folio, MBA, MS, RAC

Principal Consultant

Lindsey Folio is a RAC Certified Regulatory Affairs professional with both an MBA and MS in Bioengineering. Lindsey Folio has over 14 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 the regulatory strategy 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, 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.

Lindsey leads the team at Folio Consulting Group, LLC. For more information on their regulatory, quality, and project management services visit their website.