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Sharlene Dai
Distinguished Toxicologist, Neuro Therapy Delivery System, Restorative Therapies Group at Medtronic

Profile

Dr. Dai is a toxicology subject matter lead at Medtronic Restorative Therapies Group, responsible for the biological safety evaluation and toxicology risk assessment through the life cycle of a wide variety of medical devices and applications globally, especially implantable devices and drug device combination products. She is a US delegate and an international expert of the ISO 10993/TC 194 Working Groups and a member of ASTM F04 committee.  Dr. Dai holds BSE in Biomedical Engineering from Southeast University, MD in Clinical Medicine from Nanjing Medical University, and PhD in Neuroscience and postdoc in Pharmacology/Toxicology from Michigan State University.  She is also a American board certified toxicologist (D.A.B.T.) and holds a regulatory affairs certificate (RAC).

Agenda Sessions

  • Experiences working with global submission: Current status and next steps?

    16:05