Usability & UX Consulting FAQ
What does a usability and UX consulting company do?
A usability and UX consulting company helps organizations improve the effectiveness, efficiency, and satisfaction of their digital products. We use research, testing, and design best practices to make sure your software, website, or device is easy to use and meets user needs. In healthcare, this includes EHR Safety-Enhanced Design (SED), FDA 510(k) human factors validation, and compliance with ONC and international standards.
What industries do you serve?
We specialize in healthcare IT, EHR vendors, and medical device manufacturers, but also work with finance, government, and other high-stakes industries. Our clients are based in the Washington DC metro area, across the USA, and internationally.
How do you help with EHR Safety-Enhanced Design (SED) and ONC certification?
We guide EHR vendors through the ONC Safety-Enhanced Design (SED) process, including user-centered design, summative usability testing, and documentation for ยง170.315(b)(11) and related criteria. Our team ensures your product meets all ONC and NISTIR 7742 requirements for certification.
What is human factors validation for FDA 510(k)?
Human factors validation (or human factors validation testing) is required by the FDA for medical device 510(k) submissions. We design and conduct studies to demonstrate that your device can be used safely and effectively by intended users, following IEC 62366 and FDA guidance.
What is your process for new clients?
We start with a free consultation to understand your goals and challenges. Then we propose a tailored plan, which may include research, usability testing, design workshops, and regulatory documentation. We work flexibly with remote, national, and international teams.
What deliverables can we expect?
Typical deliverables include usability test plans and reports, human factors validation protocols, EHR SED documentation, user journey maps, wireframes, and actionable recommendations. All deliverables are designed to support compliance and real-world usability.
How do I get started?
Contact us for a free consultation! We\'ll discuss your needs and recommend the best next steps. Visit our contact page or explore our services for more information.