About Lean RAQA Systems
Michelle Lott, founder and principal of Lean RAQA Systems, started the company with an acute awareness of the unnecessary complexity prevalent in regulatory and quality functions throughout the healthcare product industry. Most companies have bulky and bureaucratic systems that are further complicated by constant regulatory change. Therefore, Lean RAQA Systems is dedicated to helping healthcare product companies navigate a complex regulatory landscape with the simplest solutions possible to ensure both regulatory and business success.
Prior to beginning her career in medical devices, Michelle served as an expert witness in forensic toxicology at the Mississippi Crime Laboratory. She received her BS in chemistry from Troy State University in Troy, AL, and achieved the Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Certification (RAC). In addition Michelle completed the RAPS Executive Development Program at Northwestern’s Kellogg School of Management.
With now nearly 20 years in the industry, Michelle has earned a reputation for creating customized, simple solutions to navigate an increasingly complex regulatory environment.
In particular, Michelle has:
- expertise to support startups needing their first quality system and submission up to large companies needing support or remediation services;
- held executive leadership roles for international regulatory and quality operations and has led large teams across many facilities; and
- participated in industry partnerships such as the Global Enteral Feeding Device Supplier Association (GEDSA).
Michelle is currently serving a four-year term on the FDA’s Device Good Manufacturing Practices (DGMP) Advisory Committee as one of two industry representatives providing strategy and guidance to FDA on key topics. The DGMP advisory committee reviews proposed regulations for good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations on the feasibility and reasonableness of the proposed regulations.
Passionate about advocating for innovators and small companies, Michelle focuses on bringing Albert Einstein’s perspective of making “everything as simple as possible, but not simpler” to the regulatory environment.