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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Learn from our experts through live events.

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

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Health & Wellness Retail

Health & Wellness Retail

More health and wellness retailers are investing in branded medical devices and technologies that make healthcare more affordable and accessible. We help them understand and meet the unique regulatory obligations of the healthcare and device spaces

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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.
Latest Health & Wellness Retail news

The latest industry insights from our global team.

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  • Insights
Aug 17, 2022

Are US Residents Representative Usability Test Participants for the Entire World?

There are some major differences that might influence the way users interact with products between the US and Europe. Here are a few that should be considered.
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  • Insights
Jun 24, 2021

A Personal Testament to the Importance of Medical Technology

Emergo by UL human factors engineer Emilee Stanczyk offers a personal reflection on how fitness tracker design has impacted her family.
Related resources

Information and tools to advance your business.

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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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  • White Paper

Implementation of EU EUDAMED

Learn about EUDAMED database compliance requirements for medical device and in-vitro diagnostics (IVD) companies in Europe.
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