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MedTech Summit US

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December 6 - 8, 2022
Intercontinental Chicago Magnificent MileChicago, IL

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

Profile

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

  • Chairperson’s Afternoon Remarks

    1:35pm
  • Practical considerations and case studies on the implementation of final draft ISO 10993 Part 17 in biological safety risk evaluation

    4:10pm
  • Multi-Stakeholder Panel: Shared Experiences of Navigating Regulatory Challenges on Chemical Characterization & Toxicological Risk Assessments

    4:50pm

Speakers at this event