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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.
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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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US FDA formally proposes aligning Quality System Regulations with ISO 13485
  • Regulatory Update
Jan 25, 2023

US FDA Issues Final Rule to Streamline Radiological Health Regulations

The US FDA issued a final rule to streamline the radiological health regulations and clarify certain provisions.
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  • Regulatory Update
Jan 24, 2023

UK MHRA Updates Roadmap for New Medical Device Regulations

UK regulators cover near-term plans to roll out new medical device market requirements
Canada Skyline.
  • Regulatory Update
Jan 19, 2023

Canada Update: Proposed Amendments to Regulations on Licensing Drugs and Medical Devices

Health Canada is proposing amendments to regulations on licensing drugs and medical devices. Also, Health Canada published its annual adjustment of fees for the fiscal year 2023-2024.
Illustration of a checklist.
  • Regulatory Update
Jan 17, 2023

European Regulators Clarify Standard Fees for MDR, IVDR

The European Medical Device Coordination Group (MDCG) has issued new guidance on standard fees for the MDR and IVDR.

Events

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

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Scientist in lab coat working at the computer screen.
Tue Jan 31, 2023
  • Webinar

MHRA, U.K. Road Map and Swiss Regulatory Updates

In this complimentary webinar, our Emergo by UL expert will outline U.K. MHRA and Switzerland medical device regulatory updates.
  • 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.