Team

Carolyn Dorgan

Director, Technical Services

Carolyn Dorgan has 10+ years of experience in the Medical Device and Combination Product industries, including 6 years at the FDA leading the Infusion Devices team. Carolyn is active in the international regulatory community through speaking engagements and has participated in over a dozen international standards ranging from infusion devices, to needle-based injection systems, on-body delivery systems, and infant incubators. In addition, her unique approach to product development and risk management has been instrumental in working with products for which there are no established performance or regulatory standards which includes pediatric medical devices, novel on body drug delivery systems, and rare disease combination products. Carolyn has a demonstrated ability for working through complex problems at a system level to implement practical solutions using her multi-disciplinary background which includes engineering, software, cybersecurity, human factors, and business.

Academic & Professional Qualifications:

  • B.S. Biomedical Engineering, University of Minnesota

  • M.S. Technology Commercialization, University of Texas

  • ASQ Six Sigma Green Belt

  • AAMI Medical Device Quality Systems

Training, Quality Systems, and Specialties:

  • Total Product Lifecycle Management Regulatory

  • Regulatory Affairs/Strategy

  • Quality and Reliability Engineering

  • ISO 13485

  • ISO 14971

  • 21 CFR 820

  • 21 CFR Part 4

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