Biocompatibility Basics: Making Sense of the Annex A Matrix
Odete Mendes, DVM, Ph.D., DACVP, DABT
Director of Toxicology & Pathology, Eurofins Medical Device Testing
Safety Testing of Medical Devices is an FDA requirement. Guidance regarding the scope of such testing is provided to developers by ANSI/AAMI/ISO 10993-1:2009 “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.” Annex A of this document provides a summary matrix regarding the framework for
As Director of Toxicology and Pathology for PSL, Dr. Mendes is responsible for direct technical oversight for toxicological and pathological assessments of preclinical testing. She provides regulatory guidance related to the pharmaceutical, medical device, biotechnology, nutraceutical
Dr. Mendes earned a Ph.D. in Pathology at Texas A&M University and obtained her Diploma of Veterinary Medicine at Lisbon Veterinary Medical School in Portugal.