At UserWise, our mission is to inspire usability engineering best practices within medical device companies to facilitate the development of world-class medical devices. We are passionate about designing usable devices that are safe and effective and easy to use. By following the Usability Engineering Process we work collectively with your team to reduce overall medical device risk.

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Our consultants partner with medical device companies to fulfill any and all steps of the Usability Engineering Process. UserWise offers a wide range of services spanning the development cycle.  Our consultants can assist you in performing user research, constructing the use-related risk analysis, conducting formative evaluations, executing summative usability validation testing, refining user manuals, and compiling the Usability Engineering File and FDA Human Factors Engineering Submission Report.

Our team (INSERT HYPERLINK ON TEAM TO THIS NEW PAGE) 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 the Usability Engineering Processes and Procedures with an individual company’s Quality System.

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.  Contact us to learn how we can best support your team.