Innovation begins with the Human Factor. HFUX Research is a human factors (HF) consultancy, specialized in medical device development. At HFUX Research we realize that there is no one ‘cookie-cutter’ solution for all, and that is why we believe in providing customized human factors and usability strategies and solutions tailor fit to meet every organizations' medical device research and development needs. Our mission is to empower organizations around the globe, at every budget, knowledge level, and development stage, from medical device and pharmaceutical startup to Fortune 500 leaders, to realize their human factors vision and usability goals. Whether you are looking to: • perform initial research & explore product ideas • implement a HF/UE program, including templates • gather data & identify user needs & requirements • perform gap & task/workflow analyses • perform known use error & use-related risk analyses • perform comparative analysis for ANDA filings • identify use scenarios & critical & essential • render initial UI wireframes, mockups & UX designs • define use & user interface characteristics & specs • develop & usability test prototypes • integrate user workflow aligned information architecture • conduct usability, benchmark & comparative testing • design, develop & evaluate instructions for use (IFU) • execute final usability validation/summative testing • execute US & EU human factors & usability validation • seek alignment in FDA, IEC, and MDR requirements • prepare FDA/IEC documentation & HFE report Our services will guide you in the identification, planning, and execution of your customized human factors strategy and solutions. Visit our website to discover our services and learn more about how we can help you in realizing your human factors vision and usability goals.