Important Considerations for Conducting In-Home Research
Human factors engineering for medical devices and IVDs is powered by user research, and some key usability results can be effectively obtained by meeting with users in their homes.
Brexit and the UK’s Medical Device Usability Requirements
Examination of how the UK Medicines and Healthcare products Regulatory Agency (MHRA) will oversee medical device human factors engineering (HFE) and usability regulations following Brexit.
The Modern Era of Potential Use Error
Our Human Factors Research & Design team examines how smart technologies found in medical devices, consumer products and vehicles has introduced new user risks. Learn more at Emergo by UL's HFR&D division.
How to Consider Diversity and Inclusion (D&I) When Applying Human Factors Engineering to Medical Products
Incorporating D&I in your medical device HFE, design and usability effort helps your product target the widest user base possible.
Self-Selection Studies: Guarding Against Contraindicated Use of OTC Medical Products
Recommendations for devising self-selection studies necessary to help consumers understand OTC medical product indications for use.
Human Factors Considerations When Developing Rapid COVID-19 Test Kits
Rapid COVID-19 test kit manufacturers should include human factors and usability components in their product development processes.
Blended Approaches to Medical Device, IVD and Combination Product Usability Testing
An overview of in-person as well as virtual usability testing considerations for medical device, IVD as well as combination product manufacturers.
Improving Product Design Through Task Analysis
Task analysis is a powerful tool for human factors researchers seeking to identify factors that could potentially cause costly and dangerous use errors.
The European MDR and Human Factors Engineering: Evaluation of User Interface of Unknown Provenance (UOUP)
How medical device manufacturers can determine whether they qualify for UOUP designation in order to demonstrate conformity to IEC 62366, which is necessary for European MDR compliance.
Procedures for Conducting In-Person Usability Testing During COVID-19 Pandemic
Like many other human factors professionals, we paused in-person research for a couple of months as COVID-19 gained an increasing foothold on the world.