Emergo by UL insights

Aug 6, 2020

Understanding Customers and Their Needs in Human Factors Engineering

Figuring out what users hope to get out of a medical device or IVD requires asking the right questions, observing your users, and ranking their needs by priority level.

Aug 4, 2020

10 Steps to Conducting a Use-related Risk Analysis as Part of Your Human Factors Engineering Process

Use-related risk analysis (URRA) is a cornerstone activity for a thorough human factors engineering (HFE) process that meets the expectations set forth by US FDA and international reviewers.

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Jul 9, 2020

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.

Jul 6, 2020

Virtual Comfort: The Key to Successful Remote Usability Testing

How and what to provide usability test participants to obtain reliable and valid results in an era of remote and virtual interactions. Learn more at Emergo by UL's Human Factors Research & Design.

Jun 24, 2020

Design Verification and Validation Versus Human Factors Validation

In the complex world of medical device regulation, it can be difficult to keep things straight when it comes to product development.

Jun 23, 2020

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.

Jun 22, 2020

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.

Jun 15, 2020

Usability Considerations When Creating a “Go Baby Go” Car

A robotics project to help children with mobility issues offers practical lessons in human factors engineering (HFE) design.

European Commission issues MDR factsheet for Class I medical device manufacturers

Jun 9, 2020

The European MDR and Human Factors Engineering: Designing User-friendly Software User Interfaces

Emergo by UL’s Human Factors Research and Design team has extensive experience developing software user interfaces and instructional materials for various medical devices.

Jun 8, 2020

"Rushing Slowly" to Market: Applying Human Factors to Fast-tracked Medical Products

Keeping human factors engineering and usability considerations front and center when seeking expedited emergency market access for medical devices and technologies.

May 13, 2020

Handling Incidental Findings in Human Factors Research

In the course of research, the chance exists of encountering results unrelated to your study that potentially impact the lives of participants. How should you respond to such events, and how can you and your team prepare for them?

Apr 28, 2020

Implications of the New ISO 14971 Edition for Usability Engineering

The new version of the international standard features increased emphasis on several areas that will require the attention of medical device manufacturers.

Apr 20, 2020

The European MDR and Human Factors Engineering: Use-related Risks

As with the European Medical Devices Directive (MDD), the MDR expects usability engineering to be incorporated into the overall risk management and device development process.

Apr 15, 2020

Exploring the Business Benefits of Inclusive Design

Designing medical devices to be accessible to users with special needs has an ethical appeal, but it also can be good for your company's bottom line.

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Mar 26, 2020

Continuing to make progress on human factors work during the COVID-19 pandemic

Tips and recommendations for how to continue critical HFE and usability studies for medical devices while maintaining social distancing and remote work. Learn more at Emergo by UL's Human Factors Research & Design unit.

Feb 17, 2020

Human Factors Terminology Breakdown

When learning about new areas of work, understanding the important terms and their relation to one another is a great start. Medical device human factors and design fields are no different.

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