Human Factors Consulting Services, Inc. (HFCSI) is a full-service human factors research and design consulting firm with an established specialization in medical devices. HFCSI has developed a comprehensive approach to supporting FDA submissions and product design methods that yield complete traceability. Our team has expertise in deriving detailed customer needs to inform the design of both established and innovative products for U.S. and International clients. Our Core Competencies Include: • Integrated Software & Hardware Requirements • Comprehensive Behavioral and Cognitive Task Analyses • Assurance Case Development and Validation • Gap Analyses (assessment of current practices vs. best practices) • Rapid Prototyping and Design Iteration • Mobile Device Design and Integration • Formative and Summative Usability Testing • Ethnographic Testing and Interactive Focus Groups • Training and Documentation Our design approach integrates human factors, performance engineering and safety requirements across the entire product development process. From initial product inception to formal FDA submission, we can provide client-centered services for large scale system developments or small, targeted projects. Contact us today at info@hfcsi.com or (818) 280-3496.
