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

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