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Regulation, Clinical and Software for Medical Devices

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

Dona O'Neil
Associate Director, Medical & Scientific Affairs, at BD
Speaker

Profile

Dona O’Neil is an Associate Director of Medical Affairs at BD Interventional Surgery where she is responsible for clinical evidence generation supporting global registrations.

Prior to joining BD, Dona was the Founder and Principal Consultant of MedSmart where she advised clients on the strategy and implementation of the EU MDR clinical evidence requirements. Dona has experience managing product portfolios for medical device manufacturers across many therapeutic areas and all device classifications.

Dona is also an Adjunct Professor for Northeastern University’s Master’s program in Regulatory Affairs. Dona holds a Master’s Degree in Public Health from George Washington University and is certified as a clinical research professional from SOCRA.

Agenda Sessions

  • Chairperson’s Opening Remarks: Regulation, Clinical and Software for Medical Devices

    8:15am
  • Chairperson’s Afternoon Remarks: Regulation, Clinical and Software for Medical Devices

    2:10pm
  • Industry Perspective: Navigating the Clinical Evaluation Documentation Web

    11:55am