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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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Emergo by UL

We Specialize in Global Medical Device and IVD Compliance and Innovation

Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success.

FEATURED SERVICE
Build Your Team's Human Factors Expertise
Optimal Product Usability Suite (OPUS™ ) – Emergo by UL’s new human factors tools – provides training, tools, and resources.
Learn more
FEATURED SERVICE
Updated RAMS Features Offer EU IVDR Support
Discover the new PEP and PER Smart Builders, and utilize the Product Classification service for IVDR kits.
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FEATURED SOLUTION
Bundled Options: Emergo Pro and Emergo Pro Plus
RAMS premium options Emergo Pro and Emergo Pro Plus offer flexible solutions to help get medical and in vitro diagnostic devices to market.
Learn more
FEATURED SERVICE
Build Your Team's Human Factors Expertise
Optimal Product Usability Suite (OPUS™ ) – Emergo by UL’s new human factors tools – provides training, tools, and resources.
Learn more
FEATURED SERVICE
Updated RAMS Features Offer EU IVDR Support
Discover the new PEP and PER Smart Builders, and utilize the Product Classification service for IVDR kits.
Learn more
FEATURED SOLUTION
Bundled Options: Emergo Pro and Emergo Pro Plus
RAMS premium options Emergo Pro and Emergo Pro Plus offer flexible solutions to help get medical and in vitro diagnostic devices to market.
Learn more

MDR

RESOURCE CENTER

Europe's Medical Devices Regulation (MDR) went into force in May 2021, requiring action. Meet our MDR team and get complimentary educational resources on the MDR to help you comply with this new regulation.

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IVDR

RESOURCE CENTER

Europe’s In Vitro Diagnostic Devices Regulation (IVDR) brings big changes, so it is imperative to prepare yourself. Meet our IVDR experts and find related news and resources.

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 LATIN AMERICA

RESOURCE CENTER

Explore the medical device and IVD regulatory systems of Brazil and Mexico, and access growing markets throughout the region. Find out how we can help you expand your global footprint.

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News

The latest industry news and insights from our global team.

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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
New Brazil INMETRO ordinance eases inspection and documentation requirements
  • Regulatory Update
Feb 2, 2023

Brazil’s New RDC 751/2022 Incorporates European MDR Risk Classification Rules

Brazilian regulators align medical device classification rules to those of EU MDR
European Union
  • Regulatory Update
Feb 1, 2023

European Commission Proposal for Amending MDR, IVDR Makes Progress

The European Council has published a proposal for amending (EU) 2017/745 and (EU) 2017/746.
US FDA medical device user fees see modest increase for 2022
  • Regulatory Update
Jan 31, 2023

US FDA and Health Canada Launch eSTAR Pilot

The US FDA and Health Canada have announced the launch of their joint eSTAR pilot program, an interactive medical device submission form.

Events

Learn from our experts through live webinars, workshops, and tradeshows.

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  • New
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Tue Feb 14, 2023
  • Webinar

Overview of New Brazilian Regulation RDC 751/2022

In this complimentary webinar, Emergo by UL subject matter expert outline the latest updates to the new Brazil regulation.
  • New
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Tue Feb 28, 2023
  • Webinar

Designing Effective Quick Reference Guides

Watch our webinar to learn how to design safer, more usable and appealing quick reference guides for medical devices and systems.