Michelle has been doing Quality Assurance and Regulatory Affairs for over 20 years. She knows that as a startup founder and an investor you need to know where to put your efforts so that you are focusing on the important stuff. She will take you from 0 to 60 determining a startups' regulatory pathway and first quality system and submission. She also does remediation services for large companies. Serving a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP) as an advisor she reviewed feasibility and reasonableness, recommending proposed good manufacturing practice regulations in manufacturing, packing, storing, and installing devices. She was formerly an expert witness in forensic toxicology at the Mississippi Crime Laboratory. Michelle knows how to assess whether a company or an acquisition target’s RAQA issues should scuttle the deal!