Audrey Turley has over 25 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert having performed all the in vitro tests offered at Nelson Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods), and genotoxicity (Ames and chromosome aberration). Audrey also has experience performing, consulting, and training on bioburden, microbial IDs, sterility and bacteriostasis/fungistasis testing. She has trained staff within the biocompatibility department and works on a company- wide level to trouble shoot problems.
Audrey worked on the team responsible for the development of the in vitro mammalian chromosomal aberration assay as well as the in vitro irritation assay for medical devices.
Currently, Audrey leads the biocompatibility Expert Advisory Team at Nelson Labs which provides biological evaluation plans (BEP), biological evaluation reports (BER), risk assessments, and gap analyses on medical devices for a variety of purposes including submissions to FDA, EU MDR, China, Japan, and Canada as well as improving company documentation.
She is an active committee member of many working groups with the Association for the Advancement of Medical Instrumentation (AAMI) as well as the International Organization for Standardization (ISO).