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
