Iterative project workflow
Our project workflow is organized into sprints, ensuring smooth progress and adaptability. By adhering to IEC 62366-1 standards, we deliver high-quality results that meet the stringent requirements of the healthcare industry. Experience a structured approach that fosters innovation and efficiency.
Services
Innovating Healthcare with User-Centered Design
HUMAN FACTOR LAB supports healthcare organizations by guiding them through every step of the product development process—from early usability testing and UI/UX design to regulatory compliance and post-launch reviews. We don’t just advise, we actively help create safer, more efficient, and user-centered solutions. Let's improve healthcare products together!
User Research
We help you understand your users by conducting targeted usability studies and task analyses. In doing so, we identify the needs and challenges that can optimize your products. Through interviews, observations, and data analysis, we discover how users interact with your systems and where improvements are needed.
Based on these insights, we develop solutions that enhance usability, reduce errors, and increase efficiency – creating products that meet the real needs of your target audience and are intuitive to use. We align our approach with ISO standard 9241-210.
UX/UI Design
With a clear focus on usability and user-centered design, we ensure that your product meets the highest standards of safety and user experience. We take into account the requirements of IEC 62366-1 as well as FDA Human Factors guidelines. From the first prototype to the final design, we ensure that your user interface is not only intuitive and efficient but also enjoyable to use.
Our goal is to create a timeless design that will be embraced by users not only today but also in the future. We craft solutions that not only meet user expectations but exceed them – and do so in the long term.
Validation
Ensure the safety and compliance of your product through thorough formative and summative evaluations. We conduct precise usability validation that meets the requirements of the FDA, IEC 62366-1, and the MDR (EU Regulation 2017/745) and IVDR (EU Regulation 2017/746). This ensures that your product not only complies with legal standards but also meets the real needs and expectations of users. Our validation process helps identify potential usability issues early, allowing you to optimize your product before it reaches the market.
Regulatory
Navigate complex regulations such as MDR/IVDR and FDA guidelines with confidence. We streamline your path to market by ensuring your product meets all necessary regulatory requirements. Our team assists in creating compliant usability engineering files and documentation, ensuring that your product not only adheres to international standards but also facilitates a smooth approval process. By addressing regulatory challenges early, we help you save time and reduce risks, enabling you to bring your innovative solutions to market efficiently and safely.