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MedTech Summit US
November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota

Xiaoling (Sharlene) Dai, PhD, DABT
Senior Principal Toxicologist at Abbott


Dr. Dai, is a technical leader in toxicological risk and biological safety evaluation of medical devices’ product life cycle to support global regulatory submissions. Prior to joining Abbott, Dr. Dai is the Distinguished Toxicologist/Technical Fellow at Medtronic plc, responsible for the biological safety evaluation and toxicology risk assessment of a wide variety of medical devices and applications, especially Class III long-term implantable polymer devices and drug-device combination products. She is an international expert/delegate of the ISO 10993/TC 194 Working Groups. Dr. Dai holds BE in Biomedical Engineering, MD, and PhD in Neuroscience, and DABT and RAC certificates.

Agenda Sessions

  • Industry Perspective: Adhering to ISO 10993-17

  • Addressing CMR/ED (carcinogenic mutagenic reprotoxic/endocrine disruptors) requirements for MDR

  • Panel: The Future of Biocompatibility Regulation