Industry Focus

The healthcare industry is changing and we have the breadth of expertise to help you evolve with it.

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Services

Comprehensive service offerings at every point in the product life cycle.

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RAMS

A platform of digital products to improve, simplify and automate RA/QA activities

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OPUS

Emergo by UL's new human factors tool - provides training, tools, and resources.

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Software

Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.

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News

The latest industry news and insights from our global team.

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RADAR

Stay informed with the most read RA/QA medical device newsletter.

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TalkingPoints

TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.

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Resources

Information and tools to advance your business.

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Events

Learn from our experts through live events.

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About

Our global consulting team works from 20+ offices on six continents.

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Tech companies are bringing consumer-oriented connected health solutions to the regulated device market.

HealthTech

Tech companies are bringing consumer-oriented connected health solutions to the regulated device market. We help tech firms design, implement, and run quality and risk management, clinical research, usability studies, and more.

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Our expertise
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  • Service

Medical Device and IVD Registration and Approval in Hong Kong

Emergo by UL can support you by gaining regulatory approval to sell medical devices and IVDs in the Hong Kong Market. This includes full support with the compilation of the registration dossier and acting as your representative.
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  • Service

Medical Device and IVD Registration and Approval in Thailand

Medical device and IVD registration with the Thai Food and Drug Administration (FDA). Get our local support for approval.
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  • Software

Get Full Access to OPUS™

Purchase individual, team, or enterprise subscriptions to scale your organization’s medical HFE expertise. Purchase a subscription on our HFE software platform, OPUS™.
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  • Software

OPUS™ Tools

Enhance your productivity with our premium and complimentary tools. Access complimentary and premium-level HFE tools on our software platform, OPUS™ – Optimal Product Usability Suite™.
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OPUS™ eLearning

Develop a strong foundation on key HFE topics or earn a complete course certificate in Applying HFE to Medical Technology. Sign up for courses or earn your course certificates on our HFE software platform, OPUS™ – Optimal Product Usability Suite™.
Latest HealthTech news

The latest industry insights from our global team.

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2023 HFES
  • Insights
May 16, 2023

Emergo HFR&D at the 2023 HFES International Symposium on Human Factors and Ergonomics in Health Care

Part 2 of our report on key human factors engineering themes at the 2023 HFES conference
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  • Insights
Apr 18, 2023

Webinar Debrief: Designing Effective Quick Reference Guides

Quick Reference Guides (QRG) to help users and patients understand Instructions for Use
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  • Insights
Apr 18, 2023

Eye Tracking: Medical Devices Through the User's Eyes

How eye tracking technology can be applied to enhance medical device safety and usability
Residual Risk Analysis
  • Insights
Mar 16, 2023

How Can We Define Successful Task Completion Within a Usability Test?

Suggestions for defining task completion and measuring completion rates in medical device usability testing
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  • Insights
Mar 10, 2023

Wiklund's Perspective: Applying Human Factors to the Wide Spectrum of Life Science Products

How human factors engineering and usability practices can impact life sciences beyond medical devices
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  • Insights
Feb 8, 2023

Wiklund's Perspective: Patient Deaths Due to Medical Error

The central role human factors engineers play in efforts to mitigate and reduce medical errors
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  • Insights
Feb 3, 2023

The Age-Old Question: HFE, Usability, ID, UX or UI?

Distinctions between human factors engineering, usability and user experience
HFE metaverse
  • Insights
Dec 14, 2022

The Future of Healthcare in the Metaverse

A look at how the metaverse may affect healthcare delivery and medical product development
Related resources

Information and tools to advance your business.

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  • On-demand Webinar

Applying Human Factors in the Course of Post-Market Surveillance

Develop a greater understanding of the importance of incorporating human factors engineering (HFE) into post-market surveillance activities.
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  • On-demand Webinar

How the IVDR Impacts Intended Purpose and Classification

In this webinar, our Emergo by UL expert outlines the latest updates on how the IVDR impacts intended purpose and classification.
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  • White Paper

Clinical Data in Support of U.S. FDA 510(k) Submissions

Read this white paper to learn about FDA requirements for clinical evidence.
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  • On-demand Webinar

Software as a Medical Device (SaMD) (Presented in French)

Regardez maintenant : le logiciel en tant que dispositif médical (SaMD) : considérations réglementaires UE/USA

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