Michelle Lott


Founder and Principal,


Michelle Lott is the Founder and Principal of leanRAQA. 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 RA and QA functions to her so that they can focus on winning in the marketplace. Ms. Lott served a four-year term on FDA's Device Good Manufacturing Practices Advisory Committee (DGMP), holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.

My Session

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June 16,2022

Additive, AI, Digital Health: What FDA’s Thinking on Science and Technology Means for Orthopedics

11:15 am-12:00 pm

Room 45

June 15,2022

Do You Have a Breakthrough or De Novo Device? Here’s an Overview of the Regulatory Pathways

2:00 pm-2:45 pm

Room 45