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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.

Build Your Team's Human Factors Expertise
New: Human Factors Tools
Optimal Product Usability Suite (OPUS™ ) – Emergo by UL’s new human factors tools – provides training, tools, and resources.
Learn more
Updated RAMS Features Offer EU IVDR Support
Updated RAMS Features
Updated features offer EU IVDR Support
Discover the new PEP and PER Smart Builders, and utilize the Product Classification service for IVDR kits.
Learn more
Emergo Bundles
Emergo Bundles
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
Build Your Team's Human Factors Expertise
New: Human Factors Tools
Optimal Product Usability Suite (OPUS™ ) – Emergo by UL’s new human factors tools – provides training, tools, and resources.
Learn more
Updated RAMS Features Offer EU IVDR Support
Updated RAMS Features
Updated features offer EU IVDR Support
Discover the new PEP and PER Smart Builders, and utilize the Product Classification service for IVDR kits.
Learn more
Emergo Bundles
Emergo Bundles
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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EU flag waving in front of a building
  • Regulatory Update
Mar 20, 2023

Amendment addressing extension of the MDR transitional periods and abandoning “sell-off” provisions goes into effect

The amendment addressing the extension of the MDR transitional periods and abandoning the “sell-off” provisions has gone into force.
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
European Union
  • Regulatory Update
Mar 14, 2023

The European MDR Amendment: What to expect and When?

Key questions and answers on new amendment extending European MDR transition period
US FDA medical device user fees see modest increase for 2022
  • Regulatory Update
Mar 10, 2023

US FDA Roundup: Revised EUA for Surgical Masks; Extended MDSAP Temporary Audit Measures and More

The US FDA has issued a number of updates, including revised emergency use authorizations (EUA) for surgical masks, extended MDSAP temporary audit measures, and more.
Events

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

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International Symposium on Human Factors and Ergonomics in Health Care 2023
Sun Mar 26, 2023
  • Tradeshow

Meeting the HFE Expectations, Regulations and Standards of a Global Marketplace

Learn more about our upcoming workshops, presentations and posters at this year’s live HFES event in Orlando, FL, March 26-29.
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Wed Mar 29, 2023
  • Webinar

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

Software as a medical device (SaMD): EU/US regulatory considerations.
EU flag waving in front of a building
Thu Mar 30, 2023
  • Webinar

EU Market Regulations Update – How to Manage Expiring Notified Body Certificates

In this webinar, our Emergo by UL subject matter expert will outline the latest EU market regulatory updates.

  • New
Person using a stamp with certification printed on it
Tue Apr 11, 2023
  • Webinar

Preparing for IVDR Certification

In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest updates about preparing for IVDR certification regulation updates.