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Biocompatibility Basics: Making Sense of the Annex A Matrix
Odete Mendes, DVM, Ph.D., DACVP, DABT
Director of Toxicology & Pathology, Eurofins Medical Device Testing

Presentation Abstract:

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 development of a medical device risk assessment program. Testing performed to meet requirements of the Annex A matrix include cytotoxicity, sensitization and irritation studies, systemic toxicity, implantation, hemocompatibility and/or genetic toxicology. However, testing needs will vary based on nature and exposure duration. This presentation will help you navigate Annex A to ensure the success of your medical device.

Presenter Biography:

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 and agrichemical industries. With more than 11 years of toxicology experience, Dr. Mendes is a diplomate of the American Board of Toxicology and of the American College of Veterinary Pathologists with extensive toxicology experience.

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.

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