UserWise, Inc.

Join a free webinar brought to you by UserWise, Inc. to learn about Human Factors Validation Study Guidelines for Medical Devices, covering: 1. An overview of the U.S. FDA human factors guidance and regulations 2. What is Human Factors Validation Testing? 3. How to Identify All Critical Tasks for Human Factors Validation Testing 4. What does the FDA mean by Task Acceptance Criteria?... Sign up for this free informative webinar here: https://us02web.zoom.us//tZcld-6pqzkoE9RuwP3SfV8oY0ADKcXWv

COVID-19 Test Kits- A Promising Solution or Snake Oil? Join a free webinar brought to you by Mahiri Med & UserWise, Inc. to learn about COVID-19 Test Kits. During this webinar you will learn: What is the latest U.S. FDA stance on COVID-19 serological testing? Does FDA "Emergency Use Authorization" mean that a test kit is reliable?... What test kits are FDA Listed and what does that mean? How do I assess a serological test kit when purchasing it for my lab? In what contexts are COVID-19 test kits useful vs. not useful? It says I'm IgM positive and IgG negative...what does that mean? What is the future of COVID-19 Serological Testing? https://userwiseconsulting.com/COVID-19-test-kit-webinar

Join our free webinar to learn more about how to use postmarket surveillance data for continuous usability improvements! During this webinar you will learn: How to develop a robust and proactive plan for monitoring complaints data How to properly equip customer service representatives with tools to improve root cause determination and specificity... How to use postmarket surveillance for continuous usability improvements Impact of MDR on postmarket surveillance Using postmarket surveillance to develop a pathway to 510(k) clearance after EUA expiration Sign up now: https://us02web.zoom.us//tZElceyppz0rHdaV4hZpsvxMvrfp-BD97

Join us for a free Zoom Webinar on FDA Regulation for Face Masks and Respirators! Register in advance for this meeting: https://us02web.zoom.us//tZcufuyrqTIrEtCsfNqsYftVxnLeGR4aI We will be covering: What are the different FDA device classifications?... What are regulatory controls? What is a product code and how do I use it? What are the types of FDA submissions? What is registration and listing? What is a face mask? A respirator? What types of face masks and respirators does the FDA regulate? What is the difference between a N95 and a surgical N95? What testing is required for a surgical mask? A surgical N95? What is NIOSH and how do I get NIOSH approval? How can I tell if a respirator has been NIOSH approved? #facemasks #respirators #FDARegulation #FreeWebinar #emergencymedicine

Are you certified in BLS (Basic Life Support)? Do you live in San Jose, California or the surrounding areas? We need you for an upcoming paid study for a new AED device. It pays $350 for 2, one hour sessions! Find out if you qualify here https://forms.gle/gsjUH2UAHHjLH4bh8 Thank you for your help and please feel free to share with anyone you know who may be qualified!

Do you have a medical product that could help with the COVID-19 pandemic? UserWise is offering a webinar on Emergency Use Authorizations by the FDA this coming Tuesday, May 12th at 10 am. Join us to learn more about the EUA process. Register to save your spot: https://userwiseconsulting.com/EUA-webinar #EmergencyMedicine #MedicalDevice #EUA

We are looking for participants in our COVID-19 study If you recently have taken a COVID-19 test and want to see if you qualify to participate, please click link and complete the questionnaire (https://forms.gle/gMkiTbr65Z3Yp1my9). Please share with anyone else that you think may qualify! ... Thank you so much and please stay safe!

Participate in a study to help enable the detection of COVID-19 by downloading a secure app and recording your voice. Participants will receive a $50 gift card for completing the study https://forms.gle/gMkiTbr65Z3Yp1my9

Join us on Zoom tomorrow at 8:30am for a discussion on "How to Secure an Emergency Use Authorization for COVID-19 https://us02web.zoom.us/j/85043660945