UserWise, Inc.

UserWise’s mission is to inspire usability engineering best practices within medical device companies and to facilitate the development of usable medical devices. We are passionate about designing safe, usable, and effective medical devices. To achieve our mission, we work together with companies to fulfill any and all of the steps in the Usability Engineering Process. We offer:

-Use Specification Preparation;
-Use-Related Risk Analysis;
-Usability Study Planning;
-Formative and Summative Usability Testing;
-Labeling, Accompanying Documentation, and Training Program Review;
-Point-of-Use Reference Generation;
-Human Factors Engineering Report Creation following FDA Guidance;
-Usability Engineering File Documentation;
-Compliance Documentation to meet FDA and international regulations including IEC 62366 and 60601-1-6;
-High-level Human Factors Guidance;
-And more.

Our expertise in integrating Usability Engineering Processes and Procedures with individual company Quality Systems is unparalleled. We tailor our approach to most efficiently meet your company’s exact needs. UserWise consultants have a successful track-record of supporting small start-up companies through fortune 500 businesses and offering Human Factors training worldwide, ranging from 1-hour lunch and learns in Washington D.C. to 2-day seminars in Uppsala, Sweden. Overall, we aim to make ourselves “obsolete” to the business as quickly as possible through training and empowerment. That is, we want to foster self-sufficient usability engineering programs in companies worldwide, to minimize the need to “lean” on consultants.

Contact UserWise to learn how we can support your usability engineering needs.
Phone: (650) 996-7480
Email: [email protected]

Company’s Keywords:

usability engineering, regulatory consulting, human factors engineering, quality consulting