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919 The Alameda, San Jose, CA 95126, USA
San Jose
United States of America
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Scale: 11-50
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1 year, 2 months agoImproving Outcomes for medical devices through human factors and usability engineering
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: userwise@UserWiseConsulting.com
UserWise, LLC is a ClariMed, Inc. company.
Usability Engineering, Regulatory Consulting, Human Factors Engineering, and Quality Consulting
UserWise offers innovative human factors consulting for the development of safe and effective world-class medical products. We work together with your company to fulfill any and all aspects of the Usability Engineering Process for medical devices and combination products. Whether you need on-going support or a one-time strategy consult, UserWise consultants offer unparalleled human factors expertise across numerous medical disciplines. By combining our usability expertise with your talents in product development, together we can achieve unrivaled and safe medical innovation. Learn More!