UserWise is proud to announce that Prescient Surgical’s CleanCision™ Wound Retraction and Protection System has received FDA 510(k) clearance! UserWise worked closely with Prescient Surgical in conducting Human Factors testing to minimize potential use errors associated with the use of CleanCision™. Learn more about CleanCision™ here!
The UserWise Blog
UserWise’s Shannon Clark recently participated in an expert panel discussion hosted by the San Francisco Bay Area Biomedical Engineering Society focusing on important questions that companies encounter when trying to apply Human Factors and Usability for Medical Devices. A variety of questions, originating from the audience and from the experts own experience, were deliberated and answered throughout the night. The common theme that emerged from this panel was that human factors is now being recognized as an essential part of the medical device development process...Read More
Shannon will be leading a pre-conference workshop at the next PFS & Injectables Summit in San Diego. On Tuesday, September 26, Shannon will be leading Workshop B on Use-Related Risk Management - Develop a Safe & Usable Medical Device. For more information regarding the PFS & Injectables Summit, visit the event page at http://pfs-injectables.com/ and registration is 20% off for being in Shannon's network.
Human Factors Engineering, an important facet of product development focused on minimizing or eliminating human error through the design of a medical product, is now becoming one of the most critical stages in the design process for medical devices. Shannon Clark, CEO of UserWise, has written an in-depth article on Human Factors and Usability Engineering for Medical Devices that has been...Read More