Team

Courtney Evans

Principal Consultant

Courtney has over 8 years of experience in medical device and drug delivery development and regulation, including over 4 years at the FDA as a Reviewer and Team Leader of injection device combination products. They bring a passion and natural proclivity for complex combination product regulatory strategy, as evidenced by their contributions to policy development of connected “smart” drug delivery devices, on-body delivery systems, emergency-use injectors and implantable infusion pumps. Courtney’s passion for combination product development is bolstered by their prior experience as a test/quality engineer, supporting medical device programs and process improvement initiatives. Their collaboration with the global regulatory community extends to speaking engagements at various international conferences.

Academic & Professional Qualifications:

  • B.S. Biomedical Engineering, Tulane University

  • B.S. Chemistry, Xavier University of Louisiana

  • M.S.(c) Materials Science and Engineering, Johns Hopkins University

  • AAMI Medical Device Quality Systems

Training, Quality Systems, & Specialties:

  • 21 CFR Part 4

  • 21 CFR Part 820

  • ISO 13485

  • ISO 14971

  • ISO 17025

  • Combination Product Design, Development and Regulation

  • Connected Drug Delivery Systems

  • Regulatory Strategy

  • Total Product Lifecycle Management

  • GLP Test Method and Report Development

  • Verification Test Engineering

  • CAPAs

  • Digital Health Policy

  • Lean Six Sigma