인사이트

Globe with push pins indicating certain countries.

2024년1월24일

Conducting HFE Activities to Meet Global Human Factors Engineering Requirements

Human Factors Engineering (HFE) requirements for medical devices vary across different countries and regions. As a result, medical device manufacturers face the challenge of meeting multiple sets of requirements to market their products in different countries.

Magnifying glass showing potential use errors

2024년1월4일

Methods for Identifying Potential Use Errors

Webinar Debrief: Methods for Identifying Potential Use Errors

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2023년12월21일

The 2023 Medical Device Regulatory Year in Review

We take a look back at some of the most significant medical device and IVD regulatory and compliance developments of 2023.

2023년12월14일

Integrating User Interface Design Validation into Human Factors Studies

Learn best practices for integrating UI design validation into HF validation tests to support a smooth and productive endeavor.

2023년12월14일

Wiklund's Perspective: Emergo by UL's Human Factors Highlights in 2023

Emergo by UL’s human factors team had a productive 2023, assisting medical device and pharmaceutical companies to develop products with safety, effectiveness and ease of use in mind.

Graphic demonstrating negative transfer concept

2023년12월13일

Conducting a Threshold Analysis to Meet FDA Expectations

Threshold Analysis and FDA Expectations | Emergo by UL

Picture of blood pressure monitor with a reading displayed.

2023년12월13일

US FDA and EU Risk Classification of Medical Devices

FDA and EU Medical Device Risk Classification Impact on Human Factors

2023년12월11일

EU Compliance, Strategies and Goals for MDR and IVDR

Emergo by UL professionals gave an update on EU Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostic Devices Regulation (IVDR, 2017/746) compliance.

The Mexican flag waving at Zócalo in Mexico City

2023년12월7일

Towards Global Medical Device Regulatory Alignment: Changes in Latin American Markets

Regulators in Brazil, Mexico and other Latin American medical device markets move toward harmonization with other regions

2023년11월9일

UI Design in 5 to 9

Designers can use the principles of working memory as an aid to developing UI’s that are intuitive and not overwhelming to users.

Graph showing how human factors are affected by AI

2023년11월8일

AI and Accessibility

Here we discuss how artificial intelligence empowers accessibility.