In the COVID-19 pandemic, UserWise is armed to help you navigate Emergency Use Authorization and other new realities.
Read on to learn more.
Human Factors & Usability Engineering Services
IEC 62366-1, FDA Human Factors Engineering, IEC 60601-1-6
Additional Services During the COVID-19 Pandemic
In this unprecedented time, UserWise is ready to assist companies with COVID-19-related products, such as ventilators, in-vitro diagnostic tests (IVDs), and other medical products, to swiftly obtain and manage Emergency Use Authorization (EUA) by providing appropriate Human Factors Information to the FDA:
- Support Scientific Evidence on Safety and Effectiveness
- Perform Expert Human Factors Review of Product Design and Labeling
- Develop Instructions for Use
- Produce Fact Sheets for HCPs and Patients
- Craft Risk-Benefit Analysis
- Optimize Post-Market Surveillance Activities to Uncover Use Issues
- Plan and Execute Remote Usability Testing
In addition to these COVID-19 EUA services, the following existing UserWise services may be helpful in navigating the new reality of the pandemic:
- Create or Review Point-of-Use Reference Material
- Develop Remote Product Trainings and Training Programs