Nate Alt, Director of Regulatory Affairs & Quality Assurance at Formlabs, and Audrey Turley, Senior Biocompatibility Expert at Nelson Labs, review:
Nate has been with Formlabs for close to three years as the director of Regulatory Affairs and Quality Assurance, supporting the biological safety strategy and manufacture of new Formlabs dental and medical 3D printer materials. He holds a bachelor's degree in Pharmaceutical Sciences from the University of Toledo and has a total of 20 years working in the medical device and chemical industries. The majority of that time was spent working at a world class medical research organization managing the technical oversight of in vitro and in vivo biocompatibility testing for class I, II and III medical devices, and providing technical guidance and consulting services to new device manufactures.
Audrey Turley has over 25 years of experience working in research, laboratory, and test design function in the medical device industry. She is a biocompatibility expert having spent 15 years in the lab performing all the in vitro tests offered at Nelson Labs, which include cytotoxicity, hemolysis (PTT, PT, complement activation, and mechanical hemolysis), and genotoxicity (Ames and chromosome aberration). Audrey was responsible for the development of the in vitro mammalian chromosome aberration assay at Nelson Labs. She was also on the team at Nelson Labs which developed and validated the in vitro irritation assay for medical devices. Audrey is an active committee member of several working groups with the Association for the Advancement of Medical Instrumentation (AAMI) and on the International Standards Organization (ISO) level as well. Audrey currently leads the team of biocompatibility expert consultants at Nelson Labs.