Miki Giffin is a subject matter expert in toxicology for medical devices. She has a broad overview of what is required to support medical device biocompatibility including traditional in vivo and in vitro tests, extractable/leachable analytical chemistry testing, and toxicological risk assessment.
Giffin is responsible for consultations for biocompatibility, assessing product intended use, and understanding US FDA, ISO, and other current industry guidance for the application of successful study design for toxicological and biological testing and risk assessments. This includes initial customer consultations, project set up, research activities to support biological safety evaluations, including toxicology, biocompatibility, and chemical characterization. She also assesses a broad range of toxicological data to prepare risk assessments, evaluation reports, and test strategies to meet requirements of ISO 10993 for submission to FDA and other global regulatory organizations. She actively participates in the annual Society of Toxicology and American College of Toxicology meetings and collaborates with AAMI and ISO members in order to ensure current regulatory and best practices are followed.