UserWise, LLC Celebrates Role in Norlase Obtaining 510(k) Clearance and CE Mark Approval

UserWise, LLC Celebrates Role in Norlase Obtaining 510(k) Clearance and CE Mark Approval

UserWise, LLC, a San Jose-based human factors consultancy, is pleased to announce its instrumental role in obtaining FDA 510(k) clearance and CE Mark approval for the Norlase ECHO™ Green Pattern Laser photocoagulator. UserWise began working with Norlase in 2018 to develop and execute the... - June 23, 2023

UserWise, LLC Launches Its First eLearning Catalog

UserWise, LLC Launches Its First eLearning Catalog

UserWise, LLC, a San Jose, California-based Human Factors consultancy, has launched UserWise University, another step towards helping develop safe and usable medical devices. - December 01, 2022

UserWise Facilitates FDA Emergency Use Authorization for Detect™ Over-the-Counter COVID-19 Test

UserWise Facilitates FDA Emergency Use Authorization for Detect™ Over-the-Counter COVID-19 Test

UserWise, Inc., a San Jose, California-based Human Factors consultancy for medical products, conducted an expedited 100-participant FDA-compliant human factors study within a 3-week span to facilitate an Emergency Use Authorization (EUA) for the Detect™ COVID-19 Test for over-the-counter home use. - November 08, 2021

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