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MedTech Safety

Bio

Michelle Lott is founder and principal of leanRAQA (leanraqa.com). She's supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services – and grief counseling(!), because dealing with regulators can be emotionally draining. Her clients delegate those things to her, so they can focus on winning in the marketplace. Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP). She serves as mentor in residence for several medical device incubators and guest lectures on regulatory affairs at the Atlantic Technological Institute of Galway and John Hopkins, among others. She holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.

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