Mollie J. Holter
Principal Consultant & Owner
University of Minnesota
Founder & Owner, Mollie J. Holter has over 20 years of Microbiology experience. From the lab bench, to managing teams of scientists and engineers at leading Medical Device companies, she has a proven track record of using her strong technical background to drive biotech innovation forward while ensuring product efficacy and patient safety.
Mollie brings subject matter expertise including: Microbiology, sterilization, biocompatibility, toxicology, regulatory requirements, international standards, risk management, material/product requirement specifications, MDR compliance, CAPAs, & verification/validation.