Denise Forkey

Denise Forkey is currently Director, Human Factors at UserWise, a consultancy that helps medical device and combination product manufacturers and start-ups to design safe and easy-to-use medical products. She leads a team of human factors consultants who fulfill any and all aspects of the usability engineering process.Denise has experience performing use-related risk analyses, conducting usability testing, and implementing the usability engineering process for home-use injection products through complex robotic surgery system. Denise regularly works on human factors submission strategy and compliance documentation for FDA Human Factors Guidance, and international standards related to usability engineering (e.g., IEC 62366-1, IEC 60601-1-6, and ISO 14971). She has helped numerous UserWise clients successfully navigate FDA human factors submissions, create usability documentation for CE mark, and manage notifying body and test lab audits of the usability engineering file.Denise has been working in the medical products industry for more than 25 years and has experience in medical device testing and quality systems/engineering, with her last 6 years focusing on human factors engineering processes and testing.She holds a master’s degree in Biomedical Engineering and has severed as a board member of the national Biomedical Engineering Society and the Bio2Device group and was the founding President of the San Francisco Bay Area Chapter of the Biomedical Engineering Society.