Usability Engineering means Building Medical Devices with Less Risk.
What We Do
At UserWise, our mission is to inspire usability engineering best practices within medical device companies to facilitate the development of best-in-class medical devices. We are passionate about designing usable devices that are safe and effective. By following the Usability Engineering Process we work collectively with your team to reduce overall medical device risk.
Our consultants work together with medical device companies to fulfill any and all steps of the Usability Engineering Process. We have proven expertise in performing user research, use-related risk analysis, formative evaluations, and summative usability validation testing, as well as creating the Usability Engineering File and FDA Human Factors Engineering Submission Report for a product. Our team has successfully prepared compliance documentation for IEC 62366-1, IEC 60601-1-6, and applicable FDA Human Factors Guidances and can offer unparalleled expertise in integrating Usability Engineering Processes and Procedures with individual company Quality Systems.
UserWise consultants have a track-record of offering Human Factors trainings worldwide, ranging from 1-hour lunch and learns in Washington D.C. to two-day seminars outlining the entire Usability Engineering Process in Uppsala, Sweden.
Overall, we aim to apply human factors engineering early and often in the medical device design process to optimize the design as quickly as possible. Applying human factors engineering in a timely manner allows us to uncover use errors and refine the product to ensure safety, to delight the customer, to eliminate the need for training, and to swiftly navigate potential regulatory hurdles, ultimately saving your company money in the long run and improving customer experience and satisfaction.