Tech Talks: Test & Measurement

Handling Unexpected Biocompatibility Test Results in Medical Device Development


Getting unexpected or failing test results for any biocompatibility test can feel like the end of the line for a medical device. As a vital step in device development, biocompatibility testing has a major effect on the approval process timeline. This 10-minute Tech Talk will shed a light on the bleak consequences of unexpected biocompatibility test results. It will outline several questions designers should ask and answer throughout an investigation to understand the results and what they mean in regards to patient safety and regulatory concerns.


Audrey Turley, Director and Biocompatibility Expert, Expert Advisory Services, Nelson Labs

Audrey Turley is the Director of Expert Advisory Services at Nelson labs, where she currently leads the team of subject matter expert consultants. She has more than 25 years of experience working in research, laboratory, and test design functions in the medical device industry. Audrey is a Biocompatibility Expert with 15 years of experience in the lab performing all in vitro tests offered at Nelson Labs, which include cytotoxicity, hemolysis, and genotoxicity. She was responsible for the development of the in vitro mammalian chromosome aberration assay at Nelson Labs and was on the team that developed and validated the in vitro irritation assay for medical devices. Audrey is an active committee member of several working groups within the Association for the Advancement of Medical Instrumentation and the International Standards Organization.


Amanda Hosey, Editor, SAE Media Group

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