Stephanie Canfield, M.S.
Quality Manager &
Sr. Consultant, HFE

Stephanie is a Senior Consultant in Human Factors Engineering at Agilis Consulting Group and is active on standards committees and industry groups for medical devices and combination products. In her current role, Stephanie manages projects of varying complexity for both medical devices and combination products, preparing various documentation and executing HF evaluations. Stephanie integrates risk management and human factors to support successful regulatory submissions and ensure regulatory compliance.

Stephanie has a Master of Science in Biology and over 10 years of experience in academia and industry. Stephanie has practical experience in a range of areas, from product feasibility, research and development, process validation, quality engineering, and human factors engineering throughout the IVD, medical device, and combination product space.

Overview:

• Master's of Science in Biology

• 8+ years experience, including medical device design and development, and combination product quality engineering

Areas Of Specialty:

• Regulatory compliance

• Medical device and combination product risk management, including use-related risk assessments

• Design Controls

• Data analysis and technical writing