Denise Forkey is currently Director, Human Factors Strategy at UserWise, a consultancy that helps medical device and combination product manufacturers and start-ups design safe and easy-to-use medical products.
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 systems. 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) for home use products to robotic surgery systems. She has helped numerous UserWise clients successfully navigate FDA human factors submissions, create usability documentation for international approval, 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 7 plus years focusing on human factors/usability engineering.
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 Industry Chapter of the Biomedical Engineering Society.
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