This webinar will address proposed changes to ISO 10993-3, specifically evaluations of developmental and reproductive (DART) toxicity for medical devices.

During this webinar, you will learn:

• What changes are proposed in ISO/DIS 10993-3
• How to interpret data from various developmental and reproductive (DART) study designs
• When DART endpoints should be considered for your device
• Approaches for evaluating DART endpoints in the toxicological risk assessment (TRA)

Presenters:

	Kimberly Ehman, PhD, DABT Head of Regulatory Toxicology Eurofins Medical Device Services
As Head of Regulatory Toxicology, Kimberly Ehman leads the biocompatibility consulting and toxicological risk assessment services for Eurofins Medical Device Services North America. She has more than 20 years of toxicology and medical device experience, with expertise in toxicological risk assessments for medical devices, food and beverage products, and electronic nicotine delivery systems. Prior to joining Eurofins, she was the Director of Regulatory Toxicology and Consulting at WuXi AppTec and has also held positions at Altria Client Services (Head of Regulatory Toxicology), Toxicology Regulatory Services (Consulting Toxicologist and Program Manager), and RTI International (Research Toxicologist for Developmental and Reproductive Toxicology and Neurotoxicology). She earned her PhD from McGill University in Montréal, Canada, and conducted her postdoctoral research at the US EPA, with a focus on developmental neurotoxicology. She has been a Diplomate of the American Board of Toxicology since 2009 and an active member of the Society of Toxicology (SOT) since 2005 and the American College of Toxicology (ACT) since 2010. She is currently the VP-elect for the Medical Device and Combination Product Specialty Section (MDCPSS) of SOT and serves as an expert on several US working groups for the ISO 10993 series of standards, including ISO 10993-1 (Evaluation and testing within a risk management process), ISO 10993-3 (Tests for genotoxicity, carcinogenicity, and reproductive toxicity), and ISO 10993-17 (Toxicological risk assessment of medical device constituents).
	Megan A. Hahn, PhD, DABT Principal Toxicologist Eurofins Medical Device Services
As Principal Toxicologist for Eurofins Medical Device Services, Dr. Megan Hahn is responsible for writing biological evaluation plans and reports, as well as toxicological risk assessments of extractables and leachables data generated from medical devices. She has more than 12 years of experience in medical device biocompatibility and toxicology, previously working with NAMSA and Medtronic. Dr. Hahn holds a degree in chemistry from the University of Rochester in New York, where her studies focused on the application of semiconductor quantum dots as fluorescent labels for pathogenic bacteria. Dr. Hahn has been a Diplomate of American Board of Toxicology since 2022, and a member of the Society of Toxicology, where she has previously served as Secretary/Treasurer and Councilor of the Medical Device and Combination Product Specialty Section. She is also a member of the American Chemical Society.